Careology joins forces with remote care support firm RedArc

Digital cancer care platform Careology has joined forces with RedArc, which provides long-term support for people with serious illnesses.

RedArc has a team of registered nurses that provide support and expert advice by phone to people after referral from insurers, trade unions and groups such as trade unions.

The new partnership provides RedArc nurses with digital tools that will help them care for cancer patients.

Using leading Bluetooth wearable and connected technology, the Careology platform allows RedArc nurses to quickly view real-time health and wellbeing data, including a patient’s temperature, heart rate, mood, journal entries and activity levels.

Access to this information can help provide consistent and effective practical advice and emotional support to patients remotely.

No financial details were disclosed about this latest deal.

In October, Careology linked with doctors at the private London General Practice, a private GP group with around 50,000 people on its books.

This allowed the doctors to remotely monitor patients.

Careology launched its remote monitoring service for cancer patients in the UK last summer, with Macmillan Cancer Support among early adopters of the tool.

The company points out that it offers a way to remotely manage or proactively support patients going through gruelling and often extremely toxic treatment regimes.

Patients themselves have to reach out if they have severe symptoms or side-effects at home.

It’s also a challenge for them to recall how they felt on particular days and assessing the impact and complications of treatment can be unreliable as results.

The system produces red flags and alerts in markers such as vital signs, systemic anti-cancer toxicities and medication adherence.

This allows early and proactive interventions to support the patient, with the potential of saving lives.

The company has its own dedicated NHS division headed by Dr Henry Carleton who has already established two software businesses that serve the health service.

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To Beat COVID-19, We Need A Modern Approach to Public Health Data

To Beat COVID-19, We Need A Modern Approach to Public Health Data
Ed Simcox, Chief Strategy Officer at LifeOmic

The COVID-19 pandemic, which has taken 270,000 American lives to date, has shined a light on another crisis — the U.S. currently has no standardized system for reporting public health data. Health departments all over the country resort to using paper, fax, phone, and email to transmit and receive critical information, and essential healthcare workers are spending precious time retyping data into systems from printed reports and PDFs.

At the heart of this lack of a centralized infrastructure for reporting public health data is the 10th Amendment of the U.S. Constitution, which says, “The powers not delegated to the United States by the Constitution, nor prohibited by it to the States, are reserved to the States respectively, or to the people.” Because of this amendment, the federal government — including the CDC — is not able to mandate that states, providers, or public health entities use a centralized reporting mechanism for managing all public health data. Further, the 10th Amendment also allows states to set up their own IT systems independently of other states and the federal government. The CDC then has to beg for data that sits in bespoke, disparate information systems in each state and territory.

Congress has tried three times in the last fourteen years to fix the issue. In 2006, it passed the Pandemic and All Hazards Preparedness Act (PAHPA), which required the CDC to establish the near-real-time, electronic, nationwide, public health data-sharing capability. Four years later in 2010, the U.S. Government Accountability Office (GAO) reported that not even the most basic planning steps were taken to establish the network. 

Then in 2013, Congress passed the Pandemic and All Hazards Preparedness Reauthorization Act (PAHPRA), which unsuccessfully called for a near real-time interoperable public health data exchange network. Finally, just months before the current pandemic, Congress passed the Pandemic and All-Hazards Preparedness and Advancing Innovation Act (PAHPAI), and our need for such a system is now greater than ever.

An Interoperable Public Health Data System

The U.S. Department of Health and Human Services (HHS) needs to lead the creation of a modern public health data approach on behalf of all public health agencies throughout the country, including the CDC. HHS was given $1 Billion for public health data infrastructure modernization in the recently passed CARES Act.

A modern approach to public health data would cost a fraction of that and must consist of three things: the creation of a gateway to link and securely move data between public health entities, the adoption of and adherence to widely accepted health data standards, and the creation of a cloud-based data hub for transparent analysis and reporting of data.

Creation of a Data Gateway

Data must be complete, timely, and accurate. A single federal data gateway would allow for the secure, two-way flow of data between all of the components of the public health ecosystem. The idea is not to create new, custom systems as we have done in the past, but to create a single gateway system at the federal level that stitches all existing data systems together using modern application programming interfaces (APIs). Such a system will allow data to timely flow between jurisdictions and up to the CDC so that we can collectively inform public health decision-making and public policy. 

We should leverage recently adopted interoperability standards to connect data from existing Electronic Health Records (EHR) and insurance claims systems wherever possible to avoid duplicate entry of data by essential workers.

Adoption of a Standardized Data Model

We need to encourage state and local health organizations to use and promote a standardized approach to collecting data at the points of care, testing, and immunization. 

Fortunately, the public health data interoperability challenge can be solved by supporting the private sector’s move to a standardized data model for healthcare data. Congress spent billions of taxpayer dollars over the past several years incentivizing healthcare providers to adopt electronic health record systems and data interoperability standards, most recently as part of the 21st Century Cures Act, which just saw its regulations go into effect this year. Healthcare providers are busy preparing to accommodate the Cures Act’s updated standards and requirements. The federal government should eat its own dog food by adhering to the same standards when creating the new gateway.

The two main standards to pay attention to are Fast Healthcare Interoperability Resources (FHIR) and the United States Core Data for Interoperability (USCDI). Major IT and EHR companies like Google, Amazon, Microsoft, IBM, Oracle, Salesforce, and Cerner have pledged to support these standards meaning they can immediately begin supporting a new gateway and helping America’s public health system quickly modernize. 

A Cloud-Based Data Hub

Once the data is available, flowing, and standardized, we need a national, cloud-based data hub to begin gaining insights from COVID infection rates, vaccinations, and many other key indicators important to recovering from the pandemic.

Led by HHS with support from OMB and the White House, this new system could be set up within months. There are well-known tools and virtual computing environments that could be put to use right away. A modern data hub would benefit not only the federal government but also the research community and academia, as these organizations play very important roles in helping us further understand and respond to the pandemic.

Most importantly, such a hub would provide transparency and accountability, giving confidence in the data being reported by providing independent reproducibility of conclusions from data analysis.


About Ed Simcox

Ed Simcox is the chief strategy officer of LifeOmic, the creator of LIFE mobile apps, JupiterOne cloud compliance and security operations software, and the Precision Health Cloud platform in use at major medical and cancer centers. Prior to joining LifeOmic, Ed served as the Chief Technology Officer (CTO) at the U.S. Department of Health and Human Services (HHS), the largest civilian government agency in the world. He led efforts at HHS to effectively leverage data, technology, and innovation to improve the lives of the American people and the performance of the Department’s 29 agencies and offices. While CTO, he also served as Acting Chief Information Officer at HHS, where he oversaw the Department’s IT modernization efforts, IT operations, and cybersecurity


ICYMI: Cancer death rate continues decline due to advances in treatment

For the second year in a row, The American Cancer Society (ACS) reports a record single-year decline in cancer death rates in the United States. Each year, ACS estimates the number of new cancer cases and deaths that will occur in the United States. For nearly 30 years, the trend towards fewer cancer deaths has been moving in a positive direction with fewer deaths year after year. In their latest report, Cancer Statistics 2021, data demonstrates cancer mortality decreased 2.4% from 2017 to 2018, surpassing the record single-year decline reported in the previous year. Overall, cancer death rates have fallen 31% since peaking in 1991. As a result of continued declines, the report also finds a total of 3.2 million deaths have been avoided over this period.

Do the Pros of Brown Rice Outweigh the Cons of Arsenic?

Are there unique benefits to brown rice that would justify keeping it in our diet despite the arsenic content?

For years, warnings had been given about the arsenic levels in U.S. rice potentially increasing cancer risk, but it had never been put to the test until a study out of Harvard. The finding? “Long-term consumption of total rice, white rice or brown rice[,] was not associated with risk of developing cancer in US men and women.” This was heralded as good news. Indeed, no increased cancer risk found even among those eating five or more servings of rice per week. But, wait a second: Brown rice is a whole grain, a whole plant food. Shouldn’t brown rice be protective and not just neutral? I discuss this in my video Do the Pros of Brown Rice Outweigh the Cons of Arsenic?.

If you look at whole grains in general, there is “a significant inverse”—or protective—“association between total whole-grain intake and risk of mortality from total cancers,” that is, dying from cancer. My Daily Dozen recommendation of at least three servings of whole grains a day was associated with a 10 percent lower risk of dying from cancer, a 25 percent lower risk of dying from heart attacks or strokes, and a 17 percent lower risk of dying prematurely across the board, whereas rice consumption in general was not associated with mortality and was not found to be protective against heart disease or stroke. So, maybe this lack of protection means that the arsenic in rice is increasing disease risk, so much so that it’s cancelling out some of the benefits of whole-grain brown rice.

Consumer Reports suggested moderating one’s intake of even brown rice, but, given the arsenic problem, is there any reason we should go out of our way to retain any rice in our diet at all? With all of the other whole grain options out there, should we just skip the rice completely? Or, are there some unique benefits we can get from rice that would justify continuing to eat it, even though it has ten times more arsenic than other grains?

One study showed that “a brown rice based vegan diet” beat out the conventional Diabetes Association diet, even after adjusting for the extra belly fat lost by the subjects on the vegan diet, but that may have been due to the plant-based nature of their diet rather than just how brown rice-based it was.

Another study found a profound improvement in insulin levels after just five days eating brown rice compared to white rice, but was that just because the white rice made people worse? No, the brown rice improved things on its own, but the study was done with a South Indian population eating a lot of white rice to begin with, so this may have indeed been at least in part a substitution effect. And yet another study showed that instructing people to eat about a cup of brown rice a day “could significantly reduce weight, waist and hip circumference, BMI, Diastole blood pressure,” and inflammation—and not just because it was compared to white. However, a larger, longer study failed to see much more than a blood pressure benefit, which was almost as impressive in the white-rice group, so, overall, not too much to write home about.

Then, another study rolled around—probably the single most important study on the pro-rice sideshowing a significant improvement in artery function after eight weeks of eating about a daily cup of brown rice, but not white, as you can see at 3:18 in my video, and sometimes even acutely. If you give someone a meal with saturated fat and white rice, you can get a drop in artery function within an hour of consumption if you have some obesity-related metabolic derangements. But, if you give brown rice instead of white, artery function appears protected against the adverse effects of the meal. Okay, so brown rice does show benefits in interventional studies, but the question is whether it shows unique benefits. Instead, what about oatmeal or whole wheat?

Well, first, researchers needed to design an artery-crippling meal, high in saturated fat. They went with a Haagen Daaz, coconut cream, and egg milkshake given with a bowl of oatmeal or “a comparable bowl of whole rolled wheat.” What do you think happened? Do you think these whole grains blocked the artery-damaging effects like the brown rice did? The whole oats worked, but the whole wheat did not. So, one could argue that brown rice may have an edge over whole wheat. Do oats also have that beneficial long-term effect that brown rice did? The benefit was of a similar magnitude but did not reach statistical significance.

So, what’s the bottom line? Until we know more, my current thinking on the matter is that if you really like rice, you can moderate your risk by cutting down, choosing lower arsenic varieties, and cooking it in a way to lower exposure even further. But, if you like other whole grains just as much and don’t really care if you have rice versus quinoa or another grain, I’d choose the lower arsenic option.

Tada! Done with arsenic in the food supply—for now. Should the situation change, I’ll produce another video on the latest news. Make sure you’re subscribed so you don’t miss any updates.


Here are all 13 videos in the series, in case you missed any or want to go back and review:

And you may be interested in Benefits of Turmeric for Arsenic Exposure.

In health,

Michael Greger, M.D.

PS: If you haven’t yet, you can subscribe to my free videos here and watch my live presentations:

AZ/Daiichi Sankyo’s Enhertu gets second US cancer indication

AstraZeneca and Daiichi Sankyo’s Enhertu cancer drug has picked up a second indication, in patients who have stomach cancer and haven’t responded to Roche’s Herceptin (trastuzumab).

This latest indication adds to Enhertu first approval at the end of 2019 for advanced HER2-positive breast cancer after two or more HER2-targeted regimens.

Around one in five gastric cancers are HER2-positive, opening up a new market niche for AstraZeneca and Daiichi Sankyo, who have been working on Enhertu (trastuzumab deruxtecan) after signing a multi-billion partnership based on the drug in March 2019.

Under the terms of the companies’ partnership agreement, AZ is to pay Daiichi $115 million in a combined milestone payment covering second and third line HER-positive gastric cancer.

Sales of Enhertu in the US are recognised by Daiichi Sankyo. AstraZeneca reports its share of gross profit margin from Enhertu sales in the US as collaboration revenue in its financial statements.

The FDA approved the new use based on positive results from the randomised DESTINY-Gastric01 phase 2 trial conducted in Japan and South Korea.

In the trial, Enhertu demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) and objective response rate (ORR) versus chemotherapy (irinotecan or paclitaxel) in patients with advanced gastric cancer or gastroesophageal junction (GEJ) adenocarcinoma.

A pre-specified interim analysis showed patients treated with Enhertu had a 41% reduction in the risk of death versus patients treated with chemotherapy with a median OS of 12.5 months versus 8.4 months on chemotherapy.

Results showed a confirmed overall response rate (ORR) of 40.5% in 126 patients treated with Enhertu compared to 11.3% in patients treated with chemotherapy.

Patients treated with Enhertu had a 7.9% complete response rate and a 32.5% partial response rate compared to a complete response rate of 0% and a partial response rate of 11.3% for patients treated with chemotherapy.

It also showed a median progression-free survival (PFS) of 5.6 months compared to 3.5 months with chemotherapy.

Additionally, Enhertu showed a median duration of response (DoR) of 11.3 months versus 3.9 months with chemotherapy.

Enhertu is an antibody-drug conjugate, consisting of the trastuzumab antibody that targets HER2-positive cancers in Herceptin, with a cancer-killing payload.

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Ex-Merck & Co scientist accused of stealing trade secrets could face jail

A former Merck & Co scientist could face up to 10 years in prison after he was accused of stealing trade secrets relating to drugs including the cancer immunotherapy Keytruda by US authorities.

In a document outlining the charges against Shafat Quadri, of North Potomac, Maryland the US Department of Justice (DoJ) referred only to “one of the largest pharmaceutical companies in the world” based in New Jersey.

But supporting information refers to data from cancer drug Keytruda (pembrolizumab) and Quadri’s Linkedin profile shows he worked at New Jersey-based Merck & Co around the time of the incidents before taking a role at AstraZeneca.

Quadri, formerly Merck’s head of medical and scientific affairs, immune oncology, has been charged with one count of theft of trade secrets and one count of unauthorised transmission of trade secrets, some relating to the multi-billion dollar cancer immunotherapy Keytruda (pembrolizumab).

According to the DoJ, the company contacted the FBI in October 2019 to report suspicious activity by Quadri, who had been employed there since 2015 as director of medical and scientific affairs, immune oncology.

The company said an internal investigation found Quadri had copied and removed thousands of files containing proprietary information before he left in September 2019,

This included research protocols, data and strategic plans, using unauthorised USB devices and personal email accounts to transfer the information that he had access to as part of his job.

Some documents were copied and removed and the trade secrets were also sent to an email address controlled by his “subsequent employer” and one of Merck’s competitors, according to the document.

Quadri was not authorised to keep the documents, the DoJ noted, and the investigation showed the company regularly monitors its employees’ use of company-provided technology and systems.

The count of theft of trade secrets charge carries a maximum potential penalty of up to 10 years in prison and a fine of up to $250,000, or twice the gross pecuniary gain or loss.

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FCC Unveils 14 Initial Projects Selected for $100M Connected Care Pilot Program

FCC COVID-19 Telehealth Program Providers

What You Should Know:

– FCC announces initial 14 pilot project selected for $100M Connected Care Pilot Program that will support connected care service across the country and focus on low-income and veteran patients.


The Federal Communications
Commission (FCC)
today announced an initial set of 14 pilot projects with
over 150 treatment sites in 11 states that have been selected for the Connected
Care Pilot Program
.  A total of $26.6 million will be awarded to these
applicants for proposed projects to treat nearly half a million patients in
both urban and rural parts of the country. 


Connected Care Pilot Program Background

Overall, this Pilot Program will make available up to $100
million over a three-year period for selected pilot projects for qualifying
purchases necessary to provide connected care services, with a particular
emphasis on providing connected care services to low-income and veteran
patients.  

The Pilot
Program will use Universal Service Fund monies to help defray the costs of
connected care services for eligible health care providers, providing support
for 85% of the cost of eligible services and network equipment, which include:

1. patient
broadband Internet access services

2. health care
provider broadband data connections

3. other
connected care information services

4. certain
network equipment

These pilot projects will address a variety of critical
health issues such as high-risk pregnancy, mental health conditions, and opioid
dependency, among others. Here is the list initial list of healthcare providers
that were selected into the Pilot Program:

Banyan Community Health Center, Inc.,
Coral Gables, FL.
 
Banyan Community Health Center’s pilot project seeks $911,833 to provide
patient-based Internet-connected remote monitoring, video visits or consults,
and other diagnostics and services to low-income and veteran patients who are
suffering from chronic/long-term conditions, high-risk pregnancy, infectious
disease including COVID-19, mental health conditions, and opioid
dependency.  Banyan Community Health Center plans to serve an estimated
20,847 patients in Miami, Florida, 85% of which are low-income or veteran
patients.

Duke University Health System, Durham,
NC.
  Duke
University Health System’s pilot project seeks $1,464,759 to provide remote
patient monitoring and video visits or consults to a large number of low-income
patients suffering from heart failure, cancer, and infectious diseases. 
Duke University Health System’s pilot project plans to serve an estimated
16,000 patients in North Carolina, of which 25% are low-income.

Geisinger, consortium with sites in
Lewiston, PA; Danville, PA; Jersey Shore, PA; Bloomsburg, PA; Coal Township,
PA; and Wilkes-Barre, PA.
 
Geisinger’s pilot project seeks $1,739,100 in support to provide connected care
services and remote patient monitoring to low-income patients in rural
communities in Pennsylvania.  Geisinger’s pilot project would serve an
estimated 1,000 patients and would focus on chronic disease management and
high-risk pregnancies, while also treating infectious disease and behavioral
health conditions.  Through its pilot program, Geisinger plans to directly
connect all participating patients, 100% of whom are low-income, with broadband
Internet access service. 

Grady Health System, Atlanta, GA.  Grady Health System’s pilot
project seeks $635,596 to provide Internet connectivity to an estimated 1,896
primarily low-income and high-risk patients who are unable to utilize video
telemedicine services due to lack of a reliable network connection in
Atlanta.  The program will focus on using connected care services such as
patient remote monitoring and video visits/consults to treat vulnerable
patients with conditions such as congestive heart failure, COVID19,
hypertension, diabetes, heart disease, and HIV. 

Intermountain Centers for Human
Development, consortium with sites in Casa Grande, AZ; Nogales, AZ; Coolidge,
AZ; and Eloy, AZ. 
 Intermountain
Centers for Human Development’s pilot project seeks $237,150 in support to
treat mental health conditions, opioid dependency, and other substance abuse
disorders.  The pilot project plans to serve 3,400 patients in Arizona,
including rural areas, of which 90% are low-income.

MA FQHC Telehealth Consortium,
consortium with 76 sites in Massachusetts.
  MA FQHC Telehealth Consortium’s pilot project
seeks $3,121,879 in support to provide mental health and substance abuse
disorder treatment through remote patient monitoring, video visits, and other
remote treatment to patients in Massachusetts, including significant numbers of
veterans and low-income patients.  The pilot project will expand access to
these services by leveraging program funding to increase bandwidth at its
sites, and to provide patients with mobile hotspots.  This project would
serve 75,000 patients through 76 federally qualified health centers in
Massachusetts, including rural areas, with an intended patient population of
61.5% low-income or veteran patients.

Mountain Valley Health Center,
consortium with 7 sites in Northeastern California.
  Mountain Valley Health Center’s
pilot project seeks $550,800 in support to provide telehealth capabilities and
in-home monitoring of patients with hypertension and diabetes.  Mountain
Valley’s pilot project plans to serve an estimated 200 patients in rural
Northeastern California, of which at least 24% will be low-income patients and
10% will be veteran patients.

Neighborhood Healthcare – Escondido,
Escondido, CA, Neighborhood Healthcare – Valley Parkway, Escondido, CA,
Neighborhood Healthcare – El Cajon, El Cajon, CA, Neighborhood Healthcare –
Temecula, Temecula, CA, Neighborhood Healthcare – Pauma Valley, Pauma Valley,
CA.
  Neighborhood
Healthcare’s pilot project seeks $129,744 to provide patient broadband access
to primarily low-income patients suffering from chronic and long-term
conditions (e.g., diabetes and high blood pressure).  Neighborhood
Healthcare’s collective project plans to serve an estimated 339 patients, 97%
of which are low-income patients, in five sites serving Riverside and San Diego
counties.

OCHIN, Inc., consortium with 15 sites in
Ohio, 16 sites in Oregon, and 13 sites in Washington.
  OCHIN’s pilot project seeks
$5,834,620 in support to lead a consortium of 44 providers in Ohio, Oregon, and
Washington, encompassing 8 federally qualified health centers (FQHCs) serving
rural, urban, and tribal communities.  OCHIN’s pilot project will provide
patient broadband Internet access service and wireless connections directly to
an estimated 3,450 low-income patients to access connected care services,
including video visits, patient-based Internet-connected patient monitoring,
and remote treatment and will deliver care to treat high-risk pregnancy,
maternal health conditions, mental health conditions, and chronic and long-term
conditions such as diabetes, hypertension, and heart disease. 

Phoebe Worth Medical Center – Camilla
Clinic, Camilla, GA; Phoebe Physicians Group Inc – PPC of Buena Vista, Buena
Vista, GA; Phoebe Physicians Group – Ellaville Primary Medicine Center,
Ellaville, GA; Phoebe Physicians dba Phoebe Family Medicine & Sports
Medicine, Americus, GA; Phoebe Putney Memorial Hospital, Albany, GA; Phoebe
Putney Memorial Hospital dba Phoebe Family Medicine – Sylvester, Sylvester, GA.
  The Phoebe Putney Health System
projects seek $673,200 to provide patient-based Internet-connected remote
monitoring, video visits, and remote treatment for low-income patients
suffering from chronic conditions or mental health conditions.  These projects
plan to serve an estimated 4,007 patients, approximately 1,000 of which will be
low-income patients in six sites serving southwest Georgia. 

Summit Pacific Medical Center, Elma, WA.  Summit Pacific Medical Center’s
pilot program seeks $169,977 in support to provide patient-based
Internet-connected remote monitoring, other monitoring services, video visits,
diagnostic imaging, remote treatment and other services for veterans and
low-income patients suffering from chronic conditions, infectious diseases,
mental health conditions, and opioid dependency.  Summit Pacific Medical
Center’s pilot project would serve an estimated 25 patients in Elma,
Washington, 100% of which would be low-income or veteran patients.

Temple University Hospital,
Philadelphia, PA.
 
Temple University Hospital’s pilot project seeks $4,254,250 to provide
patient-based Internet connected remote monitoring and video visits to
patients, including low-income patients, suffering from chronic/long-term
conditions and mental health conditions.  This pilot project plans to
serve an estimated 100,000 patients in Philadelphia, Pennsylvania, 45% of which
are low-income patients. 

University of Mississippi Medical
Center, Jackson, MS.
 
The University of Mississippi Medical Center’s (UMMC) pilot project seeks
$2,377,875 in support to provide broadband Internet access service to patients,
enabling remote patient monitoring technologies and ambulatory telehealth
visits to low-income patients suffering from chronic conditions or illnesses
requiring long-term care.  UMMC’s pilot project would impact an estimated
237,120 patients across Mississippi and serve up to 6,000 patients
directly.  Of these patients, UMMC estimates that 52% would be low-income.

University of Virginia Health System,
Charlottesville, VA. 
 The
University of Virginia (UVA) Health System’s pilot project seeks $4,462,500 in
support to expand the deployment of remote patient monitoring and telehealth
services to an estimated 17,000 patients across Virginia, nearly 30% of whom
will be low-income.  The UVA Health System pilot project will support
patient broadband and information services, including systems to capture,
transmit, and store patient data to allow remote patient monitoring, two-way
video, and patient scheduling. 

NICE recommends interim funding for GSK’s Zejula in ovarian cancer

Women with newly-diagnosed advanced ovarian cancer have a new treatment option in England after NICE recommend interim funding for GlaxoSmithKline’s Zejula (niraparib) in final guidance.

Zejula competes with AstraZeneca/Merck & Co’s PARP inhibitor class rival Lynparza (olaparib) but in this case it has an advantage in this maintenance therapy use as it can be used regardless of whether the BRCA mutation is present.

GSK estimates that around 3,000 people could benefit annually from the decision covering advanced high-grade epithelial ovarian cancer, fallopian tube or primary peritoneal cancer, who have completed and shown a response to platinum-based chemotherapy.

The drug will be paid for by the Cancer Drugs Fund, which provides interim funding until further data can be gathered that can help NICE with its cost-effectiveness calculations.

This indication is supported by data from the phase 3 PRIMA study, which enrolled patients with newly diagnosed advanced ovarian cancer following a complete or partial response to platinum-based chemotherapy regardless of biomarker status.

The primary endpoint in PRIMA was progression-free survival (PFS) analysed sequentially first in patients with BRCA-like mutations, then in the overall population.

Results showed Zejula significantly improved PFS regardless of biomarker status – in patients with homologous recombination deficiency (HRd) mutations, Zejula resulted in a 57% reduction in risk of disease progression versus placebo. 

In the overall population there was a 38% reduction in the risk of disease progression or death compared with placebo.

However NICE usually requires overall survival data before making decisions on long-term funding NHS funding.

As a result, the cost-effectiveness body has decided to use the CDF until GSK has the required survival data, it said in the guidance document.

In a managed access agreement with NICE, GSK has agreed an confidential discount to the list price of £4,500 for 56 100mg capsules, excluding VAT. Zejula pills are taken three times daily.

Poly-(ADP-ribose) polymerase (PARP) inhibitors are targeted therapies that work by exploiting cancer cells’ tendency to use a back-up system to keep control of mutations in their DNA.

By interfering with this process PARP inhibitors cause cancer cells to self-destruct as genetic defects mount, while leaving healthy tissue unaffected.

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Is White Rice a Yellow-Light or Red-Light Food?

Arsenic is not just considered to be a carcinogen; it’s also designated as a “nonthreshold carcinogen, meaning that any dose, no matter how small, carries some cancer risk”—so there really isn’t a “safe” level of exposure. Given that, it may be reasonable to “use the conservative ALARA” approach, reducing exposure As Low As Reasonably Achievable.

I have a low bar for recommending people avoid foods that aren’t particularly health-promoting in the first place. Remember when that acrylamide story broke, about the chemical found concentrated in french fries and potato chips? (See my video Acrylamide in French Fries for more.) My take was pretty simple: Look, we’re not sure how bad this acrylamide stuff is, but we’re talking about french fries and potato chips, which are not healthy anyway. So, I had no problem provisionally bumping them from my list of yellow-light foods into my red-light list, from “minimize consumption” to “ideally avoid on a day-to-day basis.”

One could apply the same logic here. Junk foods made out of brown rice syrup, rice milk, and white rice are not just processed foods, but also arsenic-contaminated processed foods, so they may belong in the red zone as red-light foods we should avoid. What about something like whole brown rice? That is more difficult, because there are pros to help outweigh the cons. I discuss this in my video Is White Rice a Yellow-Light or Red-Light Food?, where you can see a graphical depiction of my traffic light food system at 0:49.

The rice industry argues that the “many health benefits of rice consumption outweigh any potential risk,” which is the same sentiment you hear coming out of Japan about the arsenic-contaminated seaweed hijiki: Yes, “the cancer risk posed by hijiki consumption exceeds this acceptable [cancer risk] level by a factor of 10,” an order of magnitude, but the Japanese Ministry of Health stresses the “possible health benefits,” such as lots of fiber and minerals, as if hijiki was the only weed in the sea. Why not choose any of the other seaweeds and get all the benefits without the arsenic? So, when the rice industry says the “many health benefits of rice consumption outweigh any potential risk,” it’s as if brown rice was the only whole grain on the planet. Can’t you get the whole grain benefits without the risks by eating oatmeal, barley, or quinoa instead? Or, is there some unique benefit to rice, such that we really should try to keep brown rice in our diet?

Consumer Reports recommended moving rice to the yellow-light zone—in other words, don’t necessarily avoid it completely, but moderate your intake. The rice industry, in a fact sheet entitled “The Consumer Reports Article is Flawed,” criticized Consumer Reports for warning people about the arsenic levels in rice, saying “[t]here is a body of scientific evidence that establishes…the nutritional benefits of rice consumption; any assessment of the arsenic levels in rice that fails to take this information into account is inherently flawed and very misleading.” The rice industry cites two pieces of evidence. First, it asserts that rice-consuming cultures tend to be healthier, but is that because of, or despite, their white rice consumption? And what about the fact that rice-eating Americans tend to be healthier? Perhaps, but they also tend to eat significantly less saturated fat. So, once again, how do we know whether it’s because of—or despite—the white rice?

The rice industry could have cited the study I discuss at 3:12 in my video that showed that brown rice intake of two or more servings a week was associated with a lower risk of diabetes, but presumably, the reason it didn’t is because intake of white rice is associated with an increased risk of diabetes, and white rice represents 95 percent of the U.S. rice industry. Switching out a third of a serving of white rice a day for brown rice might lower diabetes risk by 16 percent, but switching out that same white rice for whole grains in general, like oats or barley, might work even better! So, other grains have about ten times less arsenic and are associated with even lower disease risk. No wonder the rice industry doesn’t cite this study.

It does cite the Adventist studies, though, and some in vitro data. For example, in a petri dish, as you can see at 4:05 in my video, there are rice phytonutrients that, at greater and greater doses, can inhibit the growth of colon cancer cells while apparently leaving normal colon cells alone, which is exciting. And, indeed, those who happened to eat those phytonutrients in the form of brown rice once or more a week between colonoscopies had a 40 percent lower risk of developing polyps. (The consumption of green leafy vegetables, dried fruit, and beans were also associated with lower polyp incidence.) But, the only reason we care about the development of polyps is that polyps can turn into cancer. But, there had never been studies on brown rice consumption and cancer…until now, which I discuss in my video Do the Pros of Brown Rice Outweigh the Cons of Arsenic?.


For those unfamiliar with my traffic light system, I talk about it in my book trailer. Check out How Not to Die: An Animated Summary.

Almost there! This is the corresponding article to the 12th in my 13-video series on arsenic in the food supply. If you missed any of the first 11 videos, see:

Ready for the finale? See Do the Pros of Brown Rice Outweigh the Cons of Arsenic?.

And you may be interested in Benefits of Turmeric for Arsenic Exposure.

In health,
Michael Greger, M.D.

PS: If you haven’t yet, you can subscribe to my free videos here and watch my live presentations:

Large decline in cancer mortality

Last year, I published a paper that showed that cancer mortality rates fell by 24% between 2000 and 2016 and further that new cancer drugs accounted for saving 1.3 million lives in the US over that time period. At the end of the paper, we noted that these numbers may be conservative since the use of new innovations–such as immuno-oncology, CAR-T therapy and others–took off after 2016.

It turns out that our premonition was correct, based on the findings from the American Cancer Society’s 2021 Facts & Figures report.

From 1991 to 2018, the cancer death rate has fallen 31%. This includes a 2.4% decline from 2017 to 2018—a new record for the largest 1-year drop in the cancer death rate.

2021 Cancer Facts & Figures

Improvements in health behaviors (e.g., smoking) and new treatments have paved the way for this improvement, particularly for lung cancer.

Reductions in the lung cancer death rateaccount for almost half of the total drop in the cancer death rate from 2014 to 2018. This is thought to be due to declines in smoking, advances in early detection, and improved treatments, especially for non-small cell lung cancer (NSCLC), the most common subtype.

Note that the data don’t include the impact of COVID-19 as they only run through 2018. Further, despite the dramatic improvement in mortality, cancer is still the #2 killer in the US (ignoring COVID), just behind heart disease. However, COVID-19 has passed cancer in terms of US mortality in the spring and with the recent surge has almost certainly surpassed cancer in the fall/winter of this year.

2021 Cancer Facts & Figures

As always, there is lots of interesting information in the ACS report.

Boehringer to investigate ‘dark antigens’ with UK cancer specialist Enara

Boehringer Ingelheim has signed a strategic collaboration with UK biotech Enara Bio, focused on finding ways to fight cancer using “dark antigens” in a deal worth up to €876 million ($1.07bn).

Dark Antigens represent a new class of cancer-associated antigens that derive from the genomic “dark matter” – the portion of the human genome that is normally not expressed as protein.

These sequences are usually silenced in healthy cells but are activated and presented on tumour cells.

This makes them good targets for targeted therapies that will attack cancer cells while leaving healthy cells alone.

Dark antigens are associated with specific cancers and are shared across patients and since typically not visible to the immune system, they represent a large potential repertoire of novel antigens that can be developed as targets for new immunotherapies.

In the new collaboration, Boehringer wants to combine Enara’s expertise in antigen identification with its immune-oncology technology such as oncolytic viruses and cancer vaccines.

The discovery of shared antigens could lead to the development of vaccines that can be readily used to help a broader group of cancer patients.

Enara Bio’s proprietary technology will be used to discover and validate novel dark antigens in up to three tumour types in lung and gastrointestinal cancer.

Under the agreement, Boehringer Ingelheim has the option to license dark antigens discovered and validated by Enara Bio.

Boehringer will also be responsible for all non-clinical and clinical development, as well as marketing of associated cancer immunotherapies, including therapeutic vaccines and T-cell redirecting biologics.

Enara Bio retains rights to use any discovered antigens for use in cell therapy-based products.

Enara is eligible to receive an undisclosed upfront payment, together with research/preclinical milestones and licensing fees for each tumour type that is explored.

The Oxford-based biotech is also eligible to receive more than €876 million in clinical, regulatory and commercial milestones, in addition to royalties on future product sales.

Boehringer has been particularly active in cancer deal making, buying Swiss cancer biotech NBE-Therapeutics for €1.16bn ($1.43bn) in December, snapping up antibody-drug conjugate technology.

In the same week it bought cancer vaccine and oncolytic virus specialist Labor Dr. Merk & Kollegen.

The post Boehringer to investigate ‘dark antigens’ with UK cancer specialist Enara appeared first on .

How Much Arsenic in Rice Is Too Much?

What are some strategies to reduce arsenic exposure from rice?

Those who are exposed to the most arsenic in rice are those who are exposed to the most rice, like people who are eating plant-based, gluten-free, or dairy-free. So, at-risk populations are not just infants and pregnant women, but also those who may tend to eat more rice. What “a terrible irony for the health conscious” who are trying to avoid dairy and eat lots of whole foods and brown rice—so much so they may not only suffer some theoretical increased lifetime cancer risk, but they may actually suffer arsenic poisoning. For example, a 39-year-old woman had celiac disease, so she had to avoid wheat, barley, and rye, but she turned to so much rice that she ended up with sky-high arsenic levels and some typical symptoms, including “diarrhea, headache, insomnia, loss of appetite, abnormal taste, and impaired short-term memory and concentration.” As I discuss in my video How Much Arsenic in Rice Is Too Much, we, as doctors, should keep an eye out for signs of arsenic exposure in those who eat lots of rice day in and day out.

As you can see at 1:08 in my video, in its 2012 arsenic-in-rice exposé, Consumer Reports recommended adults eat no more than an average of two servings of rice a week or three servings a week of rice cereal or rice pasta. In its later analysis, however, it looked like “rice cereal and rice pasta can have much more inorganic arsenic—a carcinogen—than [its] 2012 data showed,” so Consumer Reports dropped its recommendation down to from three weekly servings to a maximum of only two, and that’s only if you’re not getting arsenic from other rice sources. As you can see from 1:29 in my video, Consumer Reports came up with a point system so people could add up all their rice products for the week to make sure they’re staying under seven points a week on average. So, if your only source of rice is just rice, for example, then it recommends no more than one or two servings for the whole week. I recommend 21 servings of whole grains a week in my Daily Dozen, though, so what to do? Get to know sorghum, quinoa, buckwheat, millet, oatmeal, barley, or any of the other dozen or so common non-rice whole grains out there. They tend to have negligible levels of toxic arsenic.

Rice accumulates ten times more arsenic than other grains, which helps explain why the arsenic levels in urine samples of those who eat rice tend to consistently be higher than those who do not eat rice, as you can see at 2:18 in my video. The FDA recently tested a few dozen quinoa samples, and most had arsenic levels below the level of detection, or just trace amounts, including the red quinoas that are my family’s favorite, which I was happy about. There were, however, still a few that were up around half that of rice. But, overall, quinoa averaged ten times less toxic arsenic than rice. So, instead of two servings a week, following the Consumer Reports recommendation, you could have 20. You can see the chart detailing the quinoa samples and their arsenic levels at 2:20 in my video.

So, diversifying the diet is the number-one strategy to reduce exposure of arsenic in rice. We can also consider alternatives to rice, especially for infants, and minimize our exposure by cooking rice like pasta with plenty of extra water. We found that a 10:1 water-to-rice ratio seemed best, though the data suggest the rinsing doesn’t seem to do much. We can also avoid processed foods sweetened with brown rice syrup. Is there anything else we can do at the dining room table while waiting for federal agencies to establish some regulatory limits?

What if you eat a lot of fiber-containing foods with your rice? Might that help bind some of the arsenic? Apparently not. In one study, the presence of fat did seem to have an effect, but in the wrong direction: Fat increased estimates of arsenic absorption, likely due to the extra bile we release when we eat fatty foods.

We know that the tannic acid in coffee and especially in tea can reduce iron absorption, which is why I recommend not drinking tea with meals, but might it also decrease arsenic absorption? Yes, by perhaps 40 percent or more, so the researchers suggested tannic acid might help, but they used mega doses—17 cups of tea worth or that found in 34 cups of coffee—so it isn’t really practical.

What do the experts suggest? Well, arsenic levels are lower in rice from certain regions, like California and parts of India, so why not blend that with some of the higher arsenic rice to even things out for everybody?

What?!

Another wonky, thinking-outside-the-rice-box idea involves an algae discovered in the hot springs of Yellowstone National Park with an enzyme that can volatize arsenic into a gas. Aha! Researchers genetically engineered that gene into a rice plant and were able to get a little arsenic gas off of it, but the rice industry is hesitant. “Posed with a choice between [genetically engineered] rice and rice with arsenic in it, consumers may decide they just aren’t going to eat any rice” at all.


This is the corresponding article to the 11th in a 13-video series on arsenic in the food supply. If you missed any of the first ten videos, watch them here:

You may also be interested in Benefits of Turmeric for Arsenic Exposure.

Only two major questions remain: Should we moderate our intake of white rice or should we minimize it? And, are there unique benefits to brown rice that would justify keeping it in our diet despite the arsenic content? I cover these issues in the final two videos: Is White Rice a Yellow-Light or Red-Light Food? and Do the Pros of Brown Rice Outweigh the Cons of Arsenic?.

In health,

Michael Greger, M.D.

PS: If you haven’t yet, you can subscribe to my free videos here and watch my live presentations:

Birinapant licensing; AvantGen, IGM pairs up for anti-SARS-CoV-2 antibodies; BeiGene, Novartis to co-dvelop Tislelizumab; Valo raises USD190 M; Bluebird Bio Spins-off

Medivir, IGM Biosciences enters into an exclusive licensing agreement for Birinapant

Medivir AB has entered into an exclusive licensing agreement with IGM Biosciences to receive global, exclusive development rights for Birinapant. Birinapant is a clinical-stage SMAC mimetic that degrades Inhibitors of Apoptosis Proteins (IAPs) by binding to them, ultimately leading to cell death in tumor cells. 

Further, Birinapant also complements the anti-tumor activity of the immune system. Thus, the drug appears to be a promising therapeutic agent in treating different forms of cancer in combination with other drugs. IGM-8444 is another drug that is currently being tested in a phase I dose-escalation study in patients with solid and hematologic malignancies by IGM Biosciences. It is an IgM antibody targeting Death Receptor 5 (DR5), and IGM is hoping to test Birinapant with IGM-8444 for the treatment of solid cancers later this year. 

As per the terms and conditions of the agreement, Medivir is eligible to receive an upfront payment of USD 1 million, followed by an additional USD 1.5 million after Birinapant successfully becomes a part of the Phase I trials. Medivir is also eligible to receive milestone payments up to a total of approximately USD 350 million, plus tiered royalties up to mid-teens on net sales upon the commercial approval of the drug. 

AvantGen Enters into a Licensing Agreement for its Anti-SARS-CoV-2 Antibodies with IGM Biosciences 

AvantGen has announced the licensing of a panel of its anti-SARS-CoV-2 antibody clones to IGM Biosciences for COVID-19 therapy development. It is a panel of high-affinity human monoclonal antibody clones, which binds to two distinct epitopes on the receptor-binding domain of the SARS-CoV-2 spike protein, thereby blocking the spike protein from interacting with ACE2. This eventually averts virus-induced cell-killing, also known as cytopathic effect.

Under the licensing agreement, IGM Biosciences receives the rights to convert the antibody clones into IgA or IgM format for further development for the treatment of COVID-19. While AvantGen received an upfront payment and is eligible to receive milestone and royalty payments.

The companies believe that their candidate in its original IgG format has shown potent neutralization activity in in vitro assays and in an in vivo animal model. This will have an advantage over the multiple vaccines that have been getting EUA, which are not suitable for immunocompromised patients. 

BeiGene, Novartis partner to develop cancer drug Tislelizumab, an Anti-PD-1 Antibody 

BeiGene has announced the collaboration with Novartis Pharma AG to develop, manufacture, and commercialize BeiGene’s anti-PD-1 antibody tislelizumab in the United States, Canada, Mexico, member countries of the European Union, United Kingdom, Norway, Switzerland, Iceland, Liechtenstein, Russia, and Japan. 

Already in markets in China, BeiGene’s Tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. It is approved for classical Hodgkin’s lymphoma (cHL) following at least two prior therapies and locally advanced or metastatic urothelial carcinoma (UC) with PD-L1 high expression. 

The duo will jointly develop the therapy, conducting clinical trials globally. BeiGene is eligible to receive an upfront cash payment of USD 650 million, up to USD 1.3 billion upon achieving regulatory milestones, USD 250 million for sales milestones, and royalties on future sales of tislelizumab in the licensed territory. At the same time, Novartis will take care of regulatory submissions after a transition period and for commercialization upon regulatory approvals. Besides, BeiGene has an option to co-detail the product in North America, which will be funded in part by Novartis.

Valo Raises USD 190 Million in Series B Financing and Unveils Select Therapeutic Programs

Valo has announced the closing of a USD 190 million Series B financing and unveiled select therapeutic programs. The company is creating a new systemic approach for drug discovery and development. The proceeds from Series B will continue to support the discovery and development of therapeutic programs that the company is undertaking. Further, Valo plans to use the sum to advance its proprietary Opal Computational Platform and its build working capital. 

The company plans to combine its unique human-centric dataset (over 125-million patient-years) with its Opal Computational PlatformTM with an aim to leverage machine learning and patient data for the facilitated and speedy development of products at clinical stages. Some of the key preclinical programs that Valo proudly owns include NAMPT, PARP1, USP28, and HDAC3. 

The financing was led by The Public Sector Pension Investment Board (PSP Investments), along with Valo’s existing major investors, including Flagship Pioneering and several new institutional investors, including Invus Public Equities, HBM Healthcare Investments, Atinum Investment, and Mirae Asset Capital.  

Bluebird spins off to two companies, cleaving off its gene therapy, and cancer units

Bluebird bio recently announced its plans to split its genetic disease and oncology businesses. The company has decided to prioritize its severe genetic disease unit and form its oncology business into a new company.

The decision came after the company struggled to commercialize its gene therapies, and as a result, its stocks continue to stumble down. Recently, bluebird bio decided against filing for USFDA approval for its gene therapy for sickle cell disease (SCD) for at least a minimum of 2 years. 

Another of its therapy, bb1111, a LentiGlobin treatment for SCD, was building its submission on promising data from Group C pf the HGB-206 study. The company and the agency had reached an agreement on a path to transition to commercial manufacturing using an analytical comparability strategy, including a suspension-based lentiviral vector (sLVV).

The post Birinapant licensing; AvantGen, IGM pairs up for anti-SARS-CoV-2 antibodies; BeiGene, Novartis to co-dvelop Tislelizumab; Valo raises USD190 M; Bluebird Bio Spins-off appeared first on DelveInsight Business Research.

AstraZeneca Collaborates with Adaptive on Mapping Immune Response in Cancer

Shots:

  • The companies collaborated to evaluate the use of immunoSEQ T-MAP, for which Adaptive will receive quarterly payments + sequencing and data mapping fees
  • AstraZeneca to provide cancer patients’ biological samples while Adaptive will sequence the samples & deliver TCR-antigen mapping data using its clinical immunomics database of 58B+ immune cell receptors and antigens
  • AstraZeneca gets an option to enter into an agreement with Adaptive for the development & commercialization of a CDx or therapeutic application based on T-MAP data. ImmunoSEQ T-MAP combines the sequencing and mapping capabilities of Adaptive to map TCRs to antigens, across AZ’s oncology portfolio

Click here ­to­ read full press release/ article | Ref: Adaptive | Image: Glassdoor

The post AstraZeneca Collaborates with Adaptive on Mapping Immune Response in Cancer first appeared on PharmaShots.

COVID-19 Deferrals Lead to 3 Major Conditions Payers/Providers Must Address in 2021

COVID-19 Deferrals Lead to 3 Major Conditions Payers/Providers Must Address in 2021

What You Should Know:

– COVID-19 care deferrals lead to three major boomerang
conditions that payers and providers must proactively address in 2021,
according to a newly released report by Prealize.

– COVID-19’s hidden victims—those who avoided or deferred
care during the pandemic—will increasingly return to the healthcare system, and
many will be diagnosed with new conditions at more advanced stages. Healthcare
leaders must act now to keep this boomerang from driving worse outcomes and
higher costs.


Prealize, an artificial
intelligence (AI)-enabled
predictive analytics company, today announced the
publication of a new report that explores key medical conditions payers and
providers should proactively address in 2021. Healthcare utilization for
preventive care, chronic care, and emergent care significantly decreased in
2020 due to the COVID-19
pandemic
, which will result in an influx of newly diagnosed and later stage
conditions in 2021. Prealize’s
2021 State of Health Market Report: Bracing for Impact
identifies the
top at-risk conditions based on Prealize’s claims analysis and predictive
analytics capabilities.

Report Background & Methodology

Many procedures and diagnoses fell significantly in 2020,
with several dropping nearly 50% below 2019 levels between March and June. Total
healthcare utilization fell 23% between March and August 2020, compared to the
same time period in 2019.

To explore the full scope of healthcare utilization and
procedural declines in 2020, and assess how those declines will impact
patients’ health and payers’ pocketbooks in 2021, Prealize Health conducted an
analysis of claims data from nearly 600,000 patients between March 2020 and
August 2020.

Prealize identified the three predicted conditions likely to
see the largest increase in healthcare utilization in 2021:

1. Cardiac diagnoses will increase by 18% for ischemic
heart disease and 14% for congestive heart failure

These increases will be driven by 2020 healthcare
utilization declines, for example, patients deferring family medicine and
internal medicine visits. These visits, which help flag cardiac problems and
prevent them from escalating, declined 24% between March and August of 2020.

“Cardiac illnesses are some of the most serious and
potentially fatal, so delays in diagnosis can lead to significant adverse
outcomes,” said Gordon Norman, MD, Prealize’s Chief Medical Officer.
“Without early recognition and appropriate intervention, rates of patient
hospitalization and death are likely to increase, as will associated costs of
care.”

2. Cancer diagnoses will increase by 23%

Similar to cardiac screening trends, significant declines in
2020 cancer screenings will be a key driver of this increase, with 46% fewer
colonoscopies and 32% fewer mammograms performed between March and August 2020
than during that same time period in 2019.

“Cancer doesn’t stop developing or progressing because
there’s a pandemic,” said Ronald A. Paulus, MD, President and CEO at RAPMD
Strategic Advisors, Immediate Past President and CEO of Mission Health, and one
of the medical experts interviewed for the report. “In 2021, when patients
who deferred care ultimately receive their diagnoses, their cancer sadly may be
more advanced. In addition, an increase in newly diagnosed patients may make it
harder for some patients to access care and specialists—particularly for those
patients who are insured by Medicaid or lack insurance altogether.”

3. Fractures will increase by 112%

This finding, based on combined analysis of osteoporosis
risk and fall risk, is particularly troubling for the elderly patient
population.

A key driver of increased fractures in 2021 is the number of
postponed elective orthopedic procedures in 2020, such as hip and knee
replacements. These procedural delays are likely to decrease mobility, and
therefore, increase risk of fractures from falls.

“In elderly patients, fractures are very serious events
that too often lead to decreased overall mobility and quality of life,”
said Norman. “As a result, patients may suffer from physical follow-on
events like pulmonary embolisms, and behavioral health concerns like increased
social isolation.”

Why It Matters

“These predictions are daunting, but the key is that providers and payers take action now to mitigate their effects,” said Prealize CEO Linda T. Hand. “It’s going to be critical to gain insight into populations to understand their risk at an individual level, build trust, and treat their conditions as early as possible to improve outcomes. The COVID-19 pandemic has challenged every aspect of our healthcare system, but the way to get ahead of these challenges in 2021 will be to proactively identify and address patients most at risk. We’re going to see proactive care become an important driver for success next year, as providers and payers seek to mitigate unnecessary and expensive procedures that result from 2020’s decreased medical utilization. The right predictive analytics partner will be critical to providers and payers being able to take the right course of action.”


How Risky Is the Arsenic in Rice?

Getting rice down to the so-called safe water limit for arsenic would still allow for roughly 500 times greater cancer risk than is normally considered acceptable. Given the level of arsenic in rice, how could we figure out how much rice is too much? There are no U.S. standards for arsenic in rice, even though “food sources are the main source of exposure.” There are limits on arsenic in apple juice and tap water, though. To calculate those, experts must have sat down, determined out how much arsenic a day was too much—too risky—then figured people typically drink about four to eight cups of water a day, and set the limits that way, right? Okay, well, can’t we just use their how-much-arsenic-a-day-is-too-much-arsenic-a-day number, and, based on the average arsenic content in rice, figure out how-much-rice-a-day-is-too-much-rice? I discuss this in my video How Risky Is the Arsenic in Rice?.

“The allowable level established by the FDA for arsenic in bottled water is 10 ppb,” assuming people might drink a liter a day. So, based on that daily 10 ppb limit, how much rice is that?

“Each 1 g increase in rice intake was associated with a 1% increase in urinary total arsenic, such that eating 0.56 cups [a little over a half cup] of cooked rice was considered comparable with drinking 1 L/d,” one liter per day, of that maximally contaminated water. Well, if you can eat a half cup a day, why does Consumer Reports suggest eating just a few servings of rice a week? You could eat nearly a serving every day and still stay within the daily arsenic limits set for drinking water.

Well, Consumer Reports felt the 10 ppb water standard was too lax, so, it went with the “most protective standard in the country,” at 5 ppb. Guess where it came from? New Jersey. Good for New Jersey! So, by using 5 ppb instead of 10 ppb in the calculation, you can see how Consumer Reports got to its only-a-few-servings-of-rice-a-week recommendation. Presumably, that’s based on average arsenic levels in rice. If you choose a lower-arsenic rice, one with only half the level of arsenic, can you have four servings a week instead of two? And, if you boil rice like pasta and drain off the excess water, doesn’t that also cut levels in half? If so, then you are up to about eight servings a week. Based on the water standard, apparently, you could still safely eat a serving of rice a day if you choose the right rice and cook it right. I assumed the water limit is ultra-conservative since people are expected to drink water every day of their lives, whereas most people don’t eat rice every day, seven days a week. I made that assumption, but I was wrong. It turns out the opposite is true.

All this time, I had been assuming the current drinking guideline exposure would be safe, which in terms of carcinogens, is usually “1 in a million chances of getting cancer over a lifetime.” I’ve mentioned this before. It’s how cancer-causing substances are typically regulated. If a company wants to release some new chemical, it has to show that it doesn’t cause more than one in a million excess cancer cases. Of course, there are 300 million people in this country, so that one-in-a-million doesn’t make the 300 extra families who have to deal with cancer feel any better, but that’s just the kind of agreed upon “acceptable risk.”

The problem, according to the National Research Council, is that with the current federal drinking water standard for arsenic of 10 μg/L, we are not talking about an excess cancer risk of 1 in a million people, but as high as 1 case in 300 people. Those 300 extra cases of cancer just turned into a million more cases? A million more families dealing with a cancer diagnosis? “This is 3000 times higher than a commonly accepted cancer risk for an environmental carcinogen of 1 case in 1 000 000 people.” If we were to use the normally accepted 1 in a million odds of cancer risk, the water standard would have to be 500 times lower, .02 instead of 10. Even the New Jersey standard is 250 times too high. “While this is a rather drastic difference… it underlines just how little precaution is instilled in the current guidelines.”

Hold on. So why isn’t the water standard .02 instead of 10? Because that “would be nearly impossible to implement” as we just don’t have the technology to get arsenic levels in water that low. The technologically feasible level has been estimated at 3. Okay, so why is the limit 10 and not 3? The decision to use a threshold of 10 instead of 3 was “mainly a budgetary decision.” A threshold of three would cost a lot of money.

So, the current water “safety” limit “is more motivated by politics than by technology.” Nobody wants to be told they have toxic tap water. If they did, they might demand better water treatment and that would be expensive. “As a result, many people drink water at levels very close to the current guideline… and may not be aware that they are exposed to an increased risk of cancer.” Even worse, millions of Americans drink water exceeding the legal limit, as you can see at 5:10 in my video. But, even the people living in areas that meet the legal limit “must understand that current arsenic guidelines are only marginally protective.”

Perhaps we should tell people who drink water—i.e., everyone—“that current arsenic regulations are a cost-benefit compromise and that, based on usual health risk paradigms, the standards should be much lower… People must be made aware that regulatory targets for arsenic should be as close to zero as possible,” and, when it comes to water, we should aim for the reachable limit of 3. What does this mean for rice, though?

Well, first of all, so much for just trying to get rice down to the so-called safe water limit, since that “already exceeds standard [carcinogen] risks and is based on feasibility and cost-benefit compromises,” which “allows for a roughly 500 times higher risk of cancer” than is normally considered acceptable. So, “while authorities ponder when and how they will regulate arsenic concentration in rice,” perhaps we should “curtail or strongly limit our consumption of rice.”

This is the corresponding blog post to the pivotal video in my 13-part series on arsenic in the food supply. The final three videos focus on how to deal practically with the repercussions:


If you missed any of the first nine videos, see:

You may also be interested in Benefits of Turmeric for Arsenic Exposure.

My arsenic series reminds me of the extensive video series I did on lead:

In health,

Michael Greger, M.D.

PS: If you haven’t yet, you can subscribe to my free videos here and watch my live presentations:

Pfizer deal paves way for approval of ImaginAb’s cancer imaging tech

ImaginAb has signed a deal with Pfizer, which it hopes will help it to gather information necessary for approval of its tumour imaging agent as a medical device in markets in the US and other countries.

The California-based company has signed a non-exclusive license with Pfizer to supply its 89Zr CD8 Immuno-PET agent, which can be used to image CD8 T cells in cancer patients.

Used with widely available PET scan technology, ImaginAb’s technology allows doctors to track the T-cell immune response to cancer in real time and it has already picked up a multi-party deal involving Pfizer, AstraZeneca and Takeda.

The latest deal builds on that arrangement in 2019 and while the financial deals are not disclosed, chief executive officer Ian Wilson told pharmaphorum it involves an up-front fee plus payments each time the treatment is manufactured for use.

The company argues that its technology, based on specially engineered antibody fragments, can give an accurate map of T-cell activity, giving a more representative picture of how the tumour is responding to an immunotherapy.

Information of this kind can make or break a cancer trial, giving guidance about whether a tumour is growing or has become swollen because of an incursion by T-cells.

Big pharma is catching on to the idea as companies try to find ways to determine whether immunotherapies are working and avoid expensive trial failures.

“They are looking for effective tools that allow them to read out quicker and faster and better than current methodologies,” said Wilson, who said trials have failed or been delayed because of issues with conventional invasive biopsies.

“(The technology) allows them to make decisions quicker and allows them to triage their drugs more quickly in the clinical phase.”

Equally important to the company is the safety data gathered as the technology is used as the pharma companies use it to guide development of cancer immunotherapies.

This could lead to an approval in the coming years by regulators such as the FDA, where the technology could be used as a guide by doctors to indicate whether a course of immunotherapy is working, or if another option should be used.

Wilson counts US biotech CellSight as its only direct competitor with equivalent technology, although this seems to be considerably further away from commercial use by big pharma.

“From a health economic payer point of view (our technology) allows everyone to rationalise and improve patient care,” said Wilson.

 

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Why cell therapy manufacture is a team sport

Louis van de Wiel, Vice President, Site Head EU Manufacturing, Kite, a Gilead Company, reveals the complexity that sits behind the process of individualised cell therapy – and why team culture makes it work

This thought leadership series has been paid and developed by Kite, a Gilead Company.

In 2018, we were preparing to build a European facility to produce individualised cell therapies for the treatment of cancer.

Roll on two years and the team has achieved what at the time appeared a major challenge, putting 1,000 tonnes of steel, 1,800 solar panels and 176km of network cable into the creation of a centre of excellence for cell therapy near Amsterdam in the Netherlands.

In my experience, completing the design and build of a facility such as this, through to qualification, licence and becoming fully operational, would normally take four to five years. Our ambition was always to do this within two years, a goal we achieved despite the unprecedented challenge of a global coronavirus pandemic.

Indeed, while undoubtedly putting new hurdles in our path, the arrival of COVID-19 into our lives has transformed our business and operations by presenting an opportunity to be adaptable, flexible and responsive – and to continually evaluate and mitigate risk.

“There is huge complexity involved in cell therapy manufacture, with hundreds of personnel responsible for ensuring the quality and supply of an individual patient’s cells”

It’s been a complex process that’s required highly technical and skilled personnel. Not only did we build a specialised facility from the ground up, but we built an organisation, from 10-15 people two years ago to more than 400 now. We put energy and emphasis into creating the right team and a culture where everyone understands the values and drivers, allowing us to operate in a collaborative and cohesive way.

Now the new €130 million, 19,000m2 manufacturing facility near Amsterdam is able to support delivery of up to 4,000 cell therapies each year for eligible cancer patients across Europe.

But backtrack to August 2018 and the very first European patients were also receiving treatment, part of an expertly crafted operation that ran in parallel to the build. Our supply chain group worked with the existing US team to manage the shipment of patients’ cells to the US for modification and their return for treatment.

Having a fully operational site in Europe versus the US has several advantages; reducing transportation time, strengthening the chain of custody and, potentially, cutting lead time to the patient by approximately one week. This allows us to potentially provide the therapy quicker for eligible cancer patients who have stopped responding to or have progressed despite other treatments. At this stage of their disease, for patients who have no other options, a week can make a difference.

The journey of the cell

The very nature of cell therapy manufacture means employees work in tightly controlled environments to ensure adherence to good manufacturing practice standards and, ultimately, to ensure the quality and integrity of the product.

Ultimately, it’s a team sport between Kite and Gilead and the 100-plus qualifying hospitals across Europe, all of which have been individually trained and assessed to ensure they are fully compliant with the necessary procedures and meet exacting standards.

So, what does the journey of the cell look like?

To achieve consistent, timely delivery of a high-quality product requires a robust and efficient approach to engineering patient’s own T cells, which in itself encompasses apheresis, cell modification and final formulation – coupled with rigorous quality control testing throughout – reflecting the highly complex nature of the manufacturing process.

Understandably, teamwork is vital and requires an integrated network and seamless communication between Kite and the treating hospital. The journey starts with the hospital making a treatment reservation through KiteKonnect and shipping of the apheresis kit to enable the process of extracting the patient’s own white blood cells, kickstarting both the chain of identity and chain of custody.

Here, our quality and supply chain experts are integral to every stage of the cell therapy manufacturing continuum to ensure the product is returned to the patient in a timely manner.

As soon as apheresis has completed, the cells are shipped in temperature-controlled conditions to our facility near Amsterdam where they are assessed for quality and condition. One patient equals one individual treatment, so it is critical to preserve the chain of custody and chain of identity to ensure the product comes back to the same patient.

Why chain of custody and identity is critical

The chain of custody and chain of identity must, therefore, go hand-in-hand. In this way, not only do we know which cells belong to which patient, but we have precise location and up-to-the-minute feedback on storage conditions to ensure quality and safety is paramount at all times.

Once the cells have completed this first stage, the manufacturing process can begin, with T cell selection, activation, and genetic modification using viral vector technology to ensure the ability to recognise the patient’s cancer cells. Cell expansion follows to multiply the modified cells into their millions.

Further critical quality testing then takes place to ensure the cells are of a required standard and to create a finished purified product, which will be stored and returned to the originator hospital in temperature-controlled conditions (see diagram below).

Several quality attributes will be tested at this stage and the cells must meet these rigorous criteria and specifications. There is huge complexity involved in cell therapy manufacturing, with hundreds of personnel responsible for ensuring the quality and supply of an individual patient’s cells.

As part of this process, the supply chain team simultaneously coordinate with the hospital to prepare the individual so when the cells are infused back to the patient they are primed to potentially fight the cancer.

Individualising the approach

In stark contrast to basic biopharmaceutical products with a robust starting material, the cells of a patient with cancer who has already undergone multiple treatments will not have the same quality. Consequently, there can be unforeseen hurdles during the process and I am proud that the team has managed each situation to safeguard the patient’s cells and ensure they receive treatment in an efficient and timely way.

This is particularly important when you consider the turnaround for each individualised product from starting material to the patient is typically four weeks – versus months or even years for a standard biopharmaceutical product.

Additionally, each patient equals one product batch – we do not keep inventory – and the potential impact on the patient if something happens to that batch is why we are so passionate. From quality manufacturing, facility engineering, supply chain, we’re driven to make sure the batch is returned to the patient safely and effectively.

What of the future? For me, it’s all about leadership, clarity, direction, and commitment of the entire team. It’s about the opportunity to be involved in an innovative field of cancer therapy where the body is stimulated to fight cancer cells. It’s about optimising the manufacturing process to become more effective and efficient. But, most of all, it’s about the patients, their care partners and families

 

This was supported by Kite, a Gilead Company
UK-CTH-2020-11-0075 | Date of preparation: December 2020

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Meaningful Use of Genomics Requires Informatics Beyond EMRs

Why EHRs fall short w/ providing valuable genetic insights
Assaf Halevy, Founder and CEO of 2bPrecise

Electronic medical records (EMRs) are widely expected to serve as a cornerstone technology that drives the delivery of modern patient care. 

But can the EMR alone support all the informatics capabilities required by an ever-evolving healthcare industry? The rapid growth of precision medicine, particularly the use of genetic and genomic information during clinical decision making, is a compelling example that functionality beyond the EMR is required. Not only does genomic data represent a category of information used differently than traditional clinical knowledge, but the volume of data generated through molecular testing alone also requires informatics and management of a higher magnitude than previously required.

The EMR is designed to reflect a snapshot (or collection of snapshots) in time: clinical summaries, annotated lab and test results, operation notes, etc. These are mostly stored as isolated documents, loosely coupled with the rest of the patient chart. They need to remain available for reference over time, in some instances, so providers can chart and contextualize ongoing trends and chronic conditions. However, these views are anchored in time and represent limited actionable value during clinical decision-making months, years, and decades later.

Genomic information, on the other hand, represents a patient’s life signature. DNA rarely changes over the course of an individual’s lifetime. This means the results from germline testing – a patient’s molecular profile – conducted early in life are relevant, meaningful, and actionable during clinical decision making far into the future. They can also deliver insights exposing heritable proclivities that may be life-changing or life-saving for family members as well.

This recognition in and of itself alerts healthcare leaders that they need to adopt an advanced, more sophisticated strategy for data governance, management, and sharing than the approach traditionally applied to other clinical information systems, such as EMRs. 

To be successful, healthcare organizations need an accelerator external to the EMR that is built on a data model unique to the management of molecular knowledge so test results and genomic insights can be used and shared across clinical specialties and care settings, as well as overtime. In addition, the rise of precision medicine requires an agile informatics platform that enables the cross-pollination of genomic data with clinical insights and ever-advancing discoveries in genomic science.

Consider these examples of how EMRs fall short of expectations for optimal use of genomic intelligence:

1. Studies have found that, despite ubiquitous availability of molecular tests, providers consistently fail to identify patients most at risk for heritable diseases. The Journal of the American Medical Informatics Association (JAMIA) recently released research showing that half the women meeting national guidelines for genetic screening are not getting the tests they need to determine their breast and ovarian cancer risk. 

The reason? “The full story of a patient’s risk for heritable cancer within their record often does not exist in a single location,” says the JAMIA article. “It is fragmented across entries created by many authors, over many years, in many locations and formats, and commonly from many different institutions in which women have received care over their lifetimes.” In other words, no matter which EMRs they use, health systems routinely miss opportunities to improve care for patients they see. To achieve greater success, providers need tools that exceed EMR functionality and span multiple clinical systems.

2. Shortly after birth, Alexander develops a seizure disorder. The neonatologist orders a germline test to help her arrive at a precise diagnosis and begin targeted treatment. This approach is successful and Alexander thrives. In addition to genomic variants identifying the cause of his seizure disorder, the test results also contain information about other heritable risk factors, including cardiovascular disease.

Decades later, in the 70s, Alexander sees his primary care provider (PCP) with a rapid heartbeat and shortness of breath. After doing routine lab work, the PCP diagnoses congestive heart failure (CHF). If, however, the PCP had access to Alexander’s genomic test results – which remain as relevant and accurate as when he was an infant – the PCP would have noted a variation that indicated the CHF was due to dilated cardiomyopathy, requiring a different treatment regime.

It is vital that health leaders immediately begin to plan an informatics strategy that accommodates genetic and genomic data while empowering providers to leverage these insights at the point of care as they make routine, yet critical, clinical decisions. As they evaluate their approach, they would do well to ask the following questions:

– Which providers in my organization are already ordering genomic tests on their patients? How are test results being stored and managed – and can they be easily shared with and accessed by others in the health system?

– As the volume of genetic and genomic testing accelerates – and it will – how will we manage the volume of data generated? How will we apply consistent governance to the ordering process? How can we ensure results will be consumed as discrete data so our organization can optimize its value now and in the future?

– What steps do we need to take so our precision medicine strategy remains current with changing science? Which informatics tools deliver access to up-to-date knowledge bases and clinical guidelines to ensure optimal medical decisions are made?

The advent of precision medicine represents a new standard of care for healthcare providers from coast to coast. Genetic and genomic information supplies a new data set that can be used to arrive at more accurate diagnoses sooner and more effective treatment faster. This, in turn, supports better outcomes, higher patient (and provider) satisfaction, and competitive differentiation for the health system adopting precision medicine first in its market.

But to capture this value, healthcare leaders must look beyond their legacy EMRs, recognizing that they were not developed nor do they have the capacity to properly handle the upcoming data revolution. Instead, industry innovators are looking for platforms agnostic to individual EMRs and integrated with molecular labs to address the next-generation demands of precision medicine.


About Assaf Halevy

Assaf Halevy is the founder and CEO of 2bPrecise, LLC, leading an international team dedicated to bridging the final mile between the science of genomics and making that data useful at the point of care. He joined Allscripts as senior vice president of products and business development in 2013 when the company acquired Israel-based dbMotion. An initial inventor and co-founder of dbMotion, Halevy helped develop the leading clinical integration and population health management platforms in the industry today.

With 13 patents pending in the areas of actionable clinical integration, interoperability, and precision medicine, Halevy leverages his industry expertise by evaluating strategic alliances and partnerships for U.S. and international markets. Halevy was invited to participate in several U.S. government activities and contribute to an HHS privacy committee task force. In 2016, he was part of a small selective group of executives invited to the White House by Vice President Joe Biden to discuss the future of interoperability.


DaVita & RenalytixAI Partner for Early Risk Identification to Help Slow Kidney Disease Progression

DaVita & RenalytixAI Partner for Early Risk Identification to Help Slow Kidney Disease Progression

What You Should Know:

– RenalytixAI and DaVita announce a program partnership that
aims to slow kidney disease progression and improve outcomes for the nation’s
estimated 37 million adults with chronic kidney disease (CKD).

– This is the first clinical-grade program that delivers
advanced early-stage prognosis and risk stratification, combined with
actionable care management to the primary care level where the majority of
kidney disease patients are being seen.

– The program will use the KidneyIntelX in vitro
diagnostic platform from RenalytixAI to perform early risk assessment; after
risk stratification, patients identified as intermediate- and high-risk will
receive care management support through DaVita’s integrated kidney care program


RenalytixAI,
a developer of AI-enabled
clinical in vitro diagnostic solutions for kidney disease, and DaVita, the largest provider
of kidney care services in the U.S., today announced a partner program aimed at
slowing disease progression and improving health outcomes for the nation’s
estimated 37 million adults with chronic kidney disease (CKD). The program is
expected to improve patient outcomes and provide meaningful cost reductions for
health care providers and payors by enabling earlier intervention for patients
with early-stage kidney disease (stages 1, 2 and 3) through actionable risk
assessments and end-to-end care management.

The collaboration is expected to launch in three major
markets this year. As the program expands, DaVita and RenalytixAI intend to
pursue risk-sharing arrangements with health care providers and payors to drive
kidney disease patient care innovation, cost efficiencies and improve quality
of life.

Why It Matters

Kidney disease currently affects over 850 million people
globally — 20 times more than cancer. As such, it is a growing concern among
healthcare companies, medical providers and the government, and researchers, who are now investigating its connection to
COVID-19. In July 2019, the Trump administration announced the Advancing American Kidney Health (AAKH) initiative. And,
now organizations, administrations, and companies are calling on the Biden-Harris administration to expand on
that initiative and prioritize kidney disease in the first 100 days. 

Early Risk Identification at Core of Innovative Kidney
Care

The program utilizes the KidneyIntelX in vitro diagnostic platform from RenalytixAI, which uses a machine-learning algorithm to assess a combination of biomarkers from a simple blood draw with features from the electronic health record to generate a patient-specific risk score. The initial version of the KidneyIntelX risk score identifies Type 2 diabetic patients with early-stage CKD as low-, intermediate- or high-risk for progressive decline in kidney function or kidney failure. The integrated program may also help reduce kidney disease misclassification, which leaves some higher-risk patients without recommended treatment. The expected outcome of the collaboration will also be used to expand indicated use claims for KidneyIntelX.

After risk stratification, program patients identified as
intermediate- and high-risk will receive care management support through
DaVita’s integrated kidney care program, for which Renalytix will compensate
DaVita in lieu of providing those services itself. DaVita’s integrated kidney
care program is comprised of a coordinated care team, practical digital health
tools, award-winning patient education and other offerings. Focused on the
patient experience, these services are designed to empower patients to be
active in their care, delay disease progression, improve outcomes and lower
costs. DaVita’s team also closely collaborates with the treating nephrologist,
who leads the care team, to create a seamless care experience.

For patients whose kidney disease does progress, earlier
intervention can provide the patient and treating nephrologist more time to
make an informed decision about the treatment option that is best for them,
including pre-emptive transplantation, home dialysis or in-center dialysis. For
those patients who choose to begin dialysis, the extra time increases their
chance for an out-patient dialysis starts, which can help them to avoid
starting dialysis with a costly hospitalization.

“This is the first clinical-grade program that delivers advanced early-stage prognosis and risk stratification, combined with actionable care management right to the primary care level where the majority of kidney disease patients are being seen,” said James McCullough, Renalytix AI Chief Executive Officer. “Making fundamental change in kidney disease health economics and outcomes must begin with providing a clear, actionable understanding of disease progression risk.”

2020’s Top 20 Digital Health M&A Deals Totaled $50B

Teladoc Health and Livongo Merge

2020’s Top 20 Digital Health M&A Deals Totaled $50B

The combination of Teladoc Health and Livongo creates a
global leader in consumer-centered virtual care. The combined company is
positioned to execute quantified opportunities to drive revenue synergies of
$100 million by the end of the second year following the close, reaching $500
million on a run-rate basis by 2025.

Price: $18.5B in value based on each share of Livongo
will be exchanged for 0.5920x shares of Teladoc Health plus cash consideration
of $11.33 for each Livongo share.


Siemens Healthineers Acquires Varian Medical

2020’s Top 20 Digital Health M&A Deals Totaled $50B

On August 2nd, Siemens Healthineers acquired
Varian Medical for $16.4B, with the deal expected to close in 2021. Varian is a
global specialist in the field of cancer care, providing solutions especially
in radiation oncology and related software, including technologies such as
artificial intelligence, machine learning and data analysis. In fiscal year 2019,
the company generated $3.2 billion in revenues with an adjusted operating
margin of about 17%. The company currently has about 10,000 employees
worldwide.

Price: $16.4 billion in an all-cash transaction.


Gainwell to Acquire HMS for $3.4B in Cash

2020’s Top 20 Digital Health M&A Deals Totaled $50B

Veritas Capital (“Veritas”)-backed Gainwell Technologies (“Gainwell”),
a leading provider of solutions that are vital to the administration and
operations of health and human services programs, today announced that they
have entered into a definitive agreement whereby Gainwell will acquire HMS, a technology, analytics and engagement
solutions provider helping organizations reduce costs and improve health
outcomes.

Price: $3.4 billion in cash.


Philips Acquires Remote Cardiac Monitoring BioTelemetry for $2.8B

2020’s Top 20 Digital Health M&A Deals Totaled $50B

Philips acquires BioTelemetry, a U.S. provider of remote
cardiac diagnostics and monitoring for $72.00 per share for an implied
enterprise value of $2.8 billion (approx. EUR 2.3 billion). With $439M in
revenue in 2019, BioTelemetry annually monitors over 1 million cardiac patients
remotely; its portfolio includes wearable heart monitors, AI-based data
analytics, and services.

Price: $2.8B ($72 per share), to be paid in cash upon
completion.


Hims & Hers Merges with Oaktree Acquisition Corp to Go Public on NYSE

Telehealth company Hims & Hers and Oaktree Acquisition Corp., a special purpose acquisition company (SPAC) merge to go public on the New York Stock Exchange (NYSE) under the symbol “HIMS.” The merger will enable further investment in growth and new product categories that will accelerate Hims & Hers’ plan to become the digital front door to the healthcare system

Price: The business combination values the combined
company at an enterprise value of approximately $1.6 billion and is expected to
deliver up to $280 million of cash to the combined company through the
contribution of up to $205 million of cash.


SPAC Merges with 2 Telehealth Companies to Form Public
Digital Health Company in $1.35B Deal

2020’s Top 20 Digital Health M&A Deals Totaled $50B

Blank check acquisition company GigCapital2 agreed to merge with Cloudbreak Health, LLC, a unified telemedicine and video medical interpretation solutions provider, and UpHealth Holdings, Inc., one of the largest national and international digital healthcare providers to form a combined digital health company. 

Price: The merger deal is worth $1.35 billion, including
debt.


WellSky Acquires CarePort Health from Allscripts for
$1.35B

2020’s Top 20 Digital Health M&A Deals Totaled $50B

WellSky, global health, and community care technology company, announced today that it has entered into a definitive agreement with Allscripts to acquire CarePort Health (“CarePort”), a Boston, MA-based care coordination software company that connects acute and post-acute providers and payers.

Price: $1.35 billion represents a multiple of greater
than 13 times CarePort’s revenue over the trailing 12 months, and approximately
21 times CarePort’s non-GAAP Adjusted EBITDA over the trailing 12 months.


Waystar Acquires Medicare RCM Company eSolutions

2020’s Top 20 Digital Health M&A Deals Totaled $50B

On September 13th, revenue cycle management
provider Waystar acquires eSolutions, a provider of Medicare and Multi-Payer revenue
cycle management, workflow automation, and data analytics tools. The
acquisition creates the first unified healthcare payments platform with both
commercial and government payer connectivity, resulting in greater value for
providers.

Price: $1.3 billion valuation


Radiology Partners Acquires MEDNAX Radiology Solutions

2020’s Top 20 Digital Health M&A Deals Totaled $50B

Radiology Partners (RP), a radiology practice in the U.S., announced a definitive agreement to acquire MEDNAX Radiology Solutions, a division of MEDNAX, Inc. for an enterprise value of approximately $885 million. The acquisition is expected to add more than 800 radiologists to RP’s existing practice of 1,600 radiologists. MEDNAX Radiology Solutions consists of more than 300 onsite radiologists, who primarily serve patients in Connecticut, Florida, Nevada, Tennessee, and Texas, and more than 500 teleradiologists, who serve patients in all 50 states.

Price: $885M


PointClickCare Acquires Collective Medical

2020’s Top 20 Digital Health M&A Deals Totaled $50B

PointClickCare Technologies, a leader in senior care technology with a network of more than 21,000 skilled nursing facilities, senior living communities, and home health agencies, today announced its intent to acquire Collective Medical, a Salt Lake City, a UT-based leading network-enabled platform for real-time cross-continuum care coordination for $650M. Together, PointClickCare and Collective Medical will provide diverse care teams across the continuum of acute, ambulatory, and post-acute care with point-of-care access to deep, real-time patient insights at any stage of a patient’s healthcare journey, enabling better decision making and improved clinical outcomes at a lower cost.

Price: $650M


Teladoc Health Acquires Virtual Care Platform InTouch
Health

2020’s Top 20 Digital Health M&A Deals Totaled $50B

Teladoc Health acquires InTouch Health, the leading provider of enterprise telehealth solutions for hospitals and health systems for $600M. The acquisition establishes Teladoc Health as the only virtual care provider covering the full range of acuity – from critical to chronic to everyday care – through a single solution across all sites of care including home, pharmacy, retail, physician office, ambulance, and more.

Price: $600M consisting of approximately $150 million
in cash and $450 million of Teladoc Health common stock.


AMN Healthcare Acquires VRI Provider Stratus Video

2020’s Top 20 Digital Health M&A Deals Totaled $50B

AMN Healthcare Services, Inc. acquires Stratus Video, a leading provider of video remote language interpretation services for the healthcare industry. The acquisition will help AMN Healthcare expand in the virtual workforce, patient care arena, and quality medical interpretation services delivered through a secure communications platform.

Price: $475M


CarepathRx Acquires Pharmacy Operations of Chartwell from
UPMC

2020’s Top 20 Digital Health M&A Deals Totaled $50B

CarepathRx, a leader in pharmacy and medication management
solutions for vulnerable and chronically ill patients, announced today a
partnership with UPMC’s Chartwell subsidiary that will expand patient access to
innovative specialty pharmacy and home infusion services. Under the $400M
landmark agreement, CarepathRx will acquire the
management services organization responsible for the operational and strategic
management of Chartwell while UPMC becomes a strategic investor in CarepathRx. 

Price: $400M


Cerner to Acquire Health Division of Kantar for $375M in
Cash

Cerner announces it will acquire Kantar Health, a leading
data, analytics, and real-world evidence and commercial research consultancy
serving the life science and health care industry.

This acquisition is expected to allow Cerner’s Learning
Health Network client consortium and health systems with more opportunities to
directly engage with life sciences for funded research studies. The acquisition
is expected to close during the first half of 2021.

Price: $375M


Cerner Sells Off Parts of Healthcare IT Business in
Germany and Spain

2020’s Top 20 Digital Health M&A Deals Totaled $50B

Cerner sells off parts of healthcare IT business in Germany and Spain to Germany company CompuGroup Medical, reflecting the company-wide transformation focused on improved operating efficiencies, enhanced client focus, a refined growth strategy, and a sharpened approach to portfolio management.

Price: EUR 225 million ($247.5M USD)


CompuGroup Medical Acquires eMDs for $240M

2020’s Top 20 Digital Health M&A Deals Totaled $50B

CompuGroup Medical (CGM) acquires eMDs, Inc. (eMDs), a
leading provider of healthcare IT with a focus on doctors’ practices in the US,
reaching an attractive size in the biggest healthcare market worldwide. With
this acquisition, the US subsidiary of CGM significantly broadens its position
and will become the top 4 providers in the market for Ambulatory Information
Systems in the US.

Price: $240M (equal to approx. EUR 203 million)


Change Healthcare Buys Back Pharmacy Network

2020’s Top 20 Digital Health M&A Deals Totaled $50B

Change
Healthcare
 buys
back
 pharmacy unit eRx Network
(“eRx”),
 a leading provider of comprehensive, innovative, and secure
data-driven solutions for pharmacies. eRx generated approximately $67M in
annual revenue for the twelve-month period ended February 29, 2020. The
transaction supports Change Healthcare’s commitment to focus on and invest in
core aspects of the business to fuel long-term growth and advance innovation.

Price: $212.9M plus cash on the balance sheet.


Walmart Acquires Medication Management Platform CareZone

2020’s Top 20 Digital Health M&A Deals Totaled $50B

Walmart acquires CareZone, a San Francisco, CA-based smartphone
service for managing chronic health conditions for reportedly $200M. By
working with a network of pharmacy partners, CareZone’s concierge services
assist consumers in getting their prescription medications organized and
delivered to their doorstep, making pharmacies more accessible to individuals
and families who may be homebound or reside in rural locations.

Price: $200M


Verisk Acquires MSP Compliance Provider Franco Signor

2020’s Top 20 Digital Health M&A Deals Totaled $50B

Verisk, a data
analytics provider, announced today that it has acquired Franco Signor, a Medicare Secondary Payer
(MSP) service provider to America’s largest insurance carriers and employers.
As part of the acquisition, Franco Signor will become part of Verisk’s Claims
Partners business, a leading provider of MSP compliance and other analytic
claim services. Claims Partners and Franco Signor will be combining forces to
provide the single best resource for Medicare compliance. 

Price: $160M


Rubicon Technology Partners Acquires Central Logic

2020’s Top 20 Digital Health M&A Deals Totaled $50B

Private equity firm Rubicon Technology Partners acquires
Central Logic, a provider of patient orchestration and tools to accelerate
access to care for healthcare organizations. Rubicon will be aggressively driving Central Logic’s
growth with additional cash investments into the business, with a focus
on product innovation, sales expansion, delivery and customer support, and
the pursuit of acquisition opportunities.

Price: $110M – $125 million, according to sources


Arsenic in Rice Milk, Rice Krispies, and Brown Rice Syrup

I recommend people switch away from using rice milk

For kids and teens, the amount of arsenic flowing through their bodies was found to be about 15 percent higher for each quarter cup of rice consumed per day, and a similar link was found in adults. A study of pregnant women found that consuming about a half cup of cooked rice per day could raise urine arsenic levels as much as drinking a liter of arsenic-contaminated water at the current upper federal safety limit. These findings “suggest that many people in the United States may be exposed to potentially harmful levels of arsenic through rice consumption.” which I explore in my video Arsenic in Rice Milk, Rice Krispies, and Brown Rice Syrup.

Do you know where Americans get most of their rice arsenic? From Rice Krispies, though brown rice crisps cereal may have twice as much, as I discuss in my video Arsenic in Rice Milk, Rice Krispies, and Brown Rice Syrup.

“Organic brown rice syrup (OBRS) is used as a sweetener in organic food products as an alternative to high-fructose corn syrup.” Big mistake, as organic brown rice syrup products “may introduce significant concentrations” of toxic arsenic into people’s diets. For example, two energy chews sweetened with brown rice syrup might hit the provisional upper daily arsenic intake based on the water standards.

“Toddler formulas with added organic brown rice syrup have 20 times higher levels of inorganic [toxic] arsenic than regular formulas,” and in older children, thanks to brown rice syrup, a few cereal bars a day “could pose a very high cancer risk.”

What about rice milk? A consensus statement of both the European and North American societies for pediatric nutrition recommends the “avoidance of rice drinks for infants and young children,” and, generally, toxic “inorganic arsenic intake in infancy and childhood should be as low as possible.”

To this end, the United Kingdom has banned the consumption of rice milk for young children, a notion with which Consumer Reports concurred, recommending no servings a week of rice milk for children and no more than half a cup a day for adults, as you can see at 1:56 in my video.

The arsenic in various brands of rice milk ranges wildly—in fact, there’s a 15-fold difference between the highest and lowest contamination, suggesting manufacturers could make low arsenic rice milk if they wanted. As you can see at 2:16 in my video, Consumer Reports found rice drinks from Pacific and Rice Dream brands were right about average, though, for Rice Dream, it appears the vanilla or chocolate flavors may be lower. It doesn’t seem we have anything to worry about with rice vinegar, but rice pasta and rice cakes end up similar to pure rice in terms of arsenic levels, which makes sense because that’s pretty much what they are—pure rice. However, pasta is boiled, so we’d expect the levels to be cut 40 to 60 percent, like when you boil and drain rice.

If you just couldn’t live without rice milk for some reason, you could make your own using lower arsenic rice, like brown basmati from India, Pakistan, or California, but then your homemade rice milk might have even less nutrition, as most of the commercial brands are at least fortified. Better options might be soy, oat, hemp, or almond milk, though you don’t want kids to be drinking too much almond milk. There have been a few case reports of little kids drinking four cups a day and running into kidney stone problems due to its relatively high oxalate content, which averages about five times more than soy milk. More on oxalates in my video series starting with Oxalates in Spinach and Kidney Stones: Should We Be Concerned?

I have about 40 videos that touch on soy milk, discussing such topics as how it may normalize development in girls and reduce breast cancer risk, as well reduce prostate cancer risk in men. Some of the latest science on soy milk includes an association with better knee x-rays, suggesting protection from osteoarthritis, and an interventional study suggesting improved gut health by boosting the growth of good bacteria. However, drinking 3 quarts a day, which is 10 to 12 daily cups, for a year may inflame your liver, but two cups a day can have an extraordinary effect on your cholesterol, causing a whopping 25 percent drop in bad cholesterol after just 21 days.

An ounce and a half of almonds, about a handful, each day, can drop LDL cholesterol 13 percent in six weeks and reduce abdominal fat, though a cup of almond milk only contains about ten almonds, which is less than a third of what was used in the study. So, it’s not clear if almond milk helps much, but there was a study on oat milk compared to rice milk. As you can see at 4:37 in my video, five weeks of oat milk lowered bad cholesterol, whereas rice milk didn’t, and even increased triglycerides and may bump blood pressure a bit. However, the oat milk only dropped LDL about 5 percent and that was with three cups a day. As plant-based alternatives go, it appears soy milk wins the day.

So, why drink rice milk at all when there are such better options? There really isn’t much nutrition in rice milk. In fact, there are case reports of severe malnutrition in toddlers whose diets were centered around rice milk due to multiple food allergies. Infants and toddlers have increased protein requirements compared to adults, so if the bulk of a child’s diet is rice milk, coconut milk, potato milk, or almond milk, they may not get enough, as you can see at 5:23 in my video. In fact, cases of kwashiorkor—that bloated-belly protein- and calorie-deficient state of malnutrition—due to rice milk have been reported in Ethiopia…and Atlanta, Georgia, because literally 99 percent of the child’s diet was rice milk. So, these malnutrition cases were not because they drank rice milk, but rather because they drank rice milk nearly exclusively. I just use these examples to illustrate the relative lack of nutrition in rice milk. If you’re going to choose a milk alternative, you might as well go for one that has less arsenic—and more nutrition.

I have released several videos on soy milk, but only one on almond milk video so far: Prostate Cancer and Organic Milk vs. Almond Milk. I plan on producing many more on choosing between various milk options, so stay tuned.


If you’ve missed any of the useful material on dietary arsenic I’ve also shared, please see:

The final four videos in this series take all of this information and try to distill it into practical recommendations:

In health,

Michael Greger, M.D.

PS: If you haven’t yet, you can subscribe to my free videos here and watch my live presentations:

 

Patient-First Model: High Tech Meets High Touch for Individuals with Rare Disorders

Patient-First Model: High Tech Meets High Touch to Optimize Data, Inform Health Care Decisions, Enhance Population Health Management for Individuals with Rare Disorders
Donovan Quill, President and CEO, Optime Care

Industry experts state that orphan drugs will be a major trend to watch in the years ahead, accounting for almost 40% of the Food and Drug Administration approvals this year. This market has become more competitive in the past few years, increasing the potential for reduced costs and broader patient accessibility. Currently, these products are often expensive because they target specific conditions and cost on average $147,000 or more per year, making commercialization optimization particularly critical for success. 

At the same time precision medicine—a disease treatment and prevention approach that takes into account individual variability in genes, environment, and lifestyle for each person—is emerging as a trend for population health management. This approach utilizes advances in new technologies and data to unlock information and better target health care efforts within populations.

This is important because personalized medicine has the capacity to detect the onset of disease at its earliest stages, pre-empt the progression of the disease and increase the efficiency of the health care system by improving quality, accessibility, and affordability.

These factors lay the groundwork for specialty pharmaceutical companies that are developing and commercializing personalized drugs for orphan and ultra-orphan diseases to pursue productive collaboration and meaningful partnership with a specialty pharmacy, distribution, and patient management service provider. This relationship offers manufacturers a patient-first model to align with market trends and optimize the opportunity, maximize therapeutic opportunities for personalized medicines, and help to contain costs of specialty pharmacy for orphan and rare disorders. This approach leads to a more precise way of predicting the prognosis of genetic diseases, helping physicians to better determine which medical treatments and procedures will work best for each patient.

Furthermore, and of concern to specialty pharmaceutical providers, is the opportunity to leverage a patient-first strategy in streamlining patient enrollment in clinical trials. This model also maximizes interaction with patients for adherence and compliance, hastens time to commercialization, and provides continuity of care to avoid lapses in therapy — during and after clinical trials through commercialization and beyond for the whole life cycle of a product. Concurrently, the patient-first approach also provides exceptional support to caregivers, healthcare providers, and biopharma partners.


Integrating Data with Human Interaction

When it comes to personalized medicine for the rare orphan market, tailoring IT, technology, and data solutions based upon client needs—and a high-touch approach—can improve patient engagement from clinical trials to commercialization and compliance. 

Rare and orphan disease patients require an intense level of support and benefit from high touch service. A care team, including the program manager, care coordinator, pharmacist, nurse, and specialists, should be 100% dedicated to the disease state, patient community, and therapy. This is a critical feature to look for when seeking a specialty pharmacy, distribution, and patient management provider. The key to effective care is to balance technology solutions with methods for addressing human needs and variability.  

With a patient-first approach, wholesale distributors, specialty pharmacies, and hub service providers connect seamlessly, instead of operating independently. The continuity across the entire patient journey strengthens communication, yields rich data for more informed decision making, and improves the overall patient experience. This focus addresses all variables around collecting data while maintaining frequent communication with patients and their families to ensure compliance and positive outcomes. 

As genome science becomes part of the standard of routine care, the vast amount of genetic data will allow the medicine to become more precise and more personal. In fact, the growing understanding of how large sets of genes may contribute to disease helps to identify patients at risk from common diseases like diabetes, heart conditions, and cancer. In turn, this enables doctors to personalize their therapy decisions and allows individuals to better calculate their risks and potentially take pre-emptive action. 

What’s more, the increase in other forms of data about individuals—such as molecular information from medical tests, electronic health records, or digital data recorded by sensors—makes it possible to more easily capture a wealth of personal health information, as does the rise of artificial intelligence and cloud computing to analyze this data. 


Telehealth in the Age of Pandemics

During the COVID-19 pandemic, and beyond, it has become imperative that any specialty pharmacy, distribution, and patient management provider must offer a fully integrated telehealth option to provide care coordination for patients, customized care plans based on conversations with each patient, medication counseling, education on disease states and expectations for each drug. 

A customized telehealth option enables essential discussions for understanding patient needs, a drug’s impact on overall health, assessing the number of touchpoints required each month, follow-up, and staying on top of side effects.

Each touchpoint has a care plan. For instance, a product may require the pharmacist to reach out to the patient after one week to assess response to the drug from a physical and psychological perspective, asking the right questions and making necessary changes, if needed, based on the patient’s daily routine, changes in behavior and so on. 

This approach captures relevant information in a standardized way so that every pharmacist and patient is receiving the same assessment based on each drug, which can be compared to overall responses. Information is gathered by an operating system and data aggregator and shared with the manufacturer, who may make alterations to the care plan based on the story of the patient journey created for them. 

Just as important, patients know that help is a phone call away and trust the information and guidance that pharmacists provide.


About Donovan Quill, President and CEO, Optime Care 

Donovan Quill is the President and CEO of Optime Care, a nationally recognized pharmacy, distribution, and patient management organization that creates the trusted path to a fulfilled life for patients with rare and orphan disorders. Donovan entered the world of healthcare after a successful coaching career and teaching at the collegiate level. His personal mission was to help patients who suffer from an orphan disorder that has affected his entire family (Alpha-1 Antitrypsin Deficiency). Donovan became a Patient Advocate for Centric Health Resources and traveled the country raising awareness, improving detection, and providing education to patients and healthcare providers.


Arsenic in Infant Rice Cereal

When it comes to rice and rice-based products, pediatric nutrition authorities have recommended that arsenic intake should be as low as possible.

“The US Food and Drug Administration (FDA) has been monitoring the arsenic content in foods” for decades, yet despite the “well-established science describing the health risks associated with arsenic exposure, no standards have been set limiting the amount of arsenic allowable in foods” in the United States. In 2001, the EPA “adopted a new stricter standard for arsenic in drinking water,” and in 2013, the FDA proposed a legal limit for apple juice. “There are still no standards for arsenic in food products despite the fact that food sources are our main source of exposure.”

Unlike the United States, China has standards. As of 2014, China set a maximum threshold of inorganic arsenic at 150 parts per billion, stricter than the World Health Organization’s limit of 200 ppb. In the United States, a 200 ppb limit wouldn’t change the cancer risk much. If we had China’s safety limits of 150 ppb, though, cancer risk would be reduced up to 23 percent and a maximum threshold of 100 ppb would lower cancer risk up to 47 percent—but that could seriously affect the rice industry. In other words, U.S. rice is so contaminated with arsenic that if a safety standard that really cut down on cancer risk were set, it “would wipe out the U.S. rice market.” However, with no limits, what’s the incentive for the rice industry to change its practices? Setting arsenic limits would not only directly protect consumers but also encourage the industry to stop planting rice paddies on arsenic-contaminated land.

Those cancer estimates are based on arsenic-contaminated water studies. Might the arsenic in rice somehow have a different effect? You don’t know…until you put it to the test. We know rice has a lot of toxic arsenic that urine studies have shown we absorb into our body, but there hadn’t been any studies demonstrating “deleterious health impacts” specific to rice arsenic—until now. Since arsenic causes bladder cancer, the researchers figured they would see what kind of DNA mutations the urine of rice eaters can have on human bladder cells growing in a petri dish. And, indeed, they clearly demonstrated that eating a lot of arsenic-contaminated rice every day can “give rise to significant amounts of genetic damage,” the kind that‘s associated with cancer. Yes, but the study used pretty contaminated rice. However, only about 10 percent of the rice in certain parts of Asia might ever reach those levels of contamination, though a quarter of rice in parts of Europe might and more half in the United States, making for considerable public health implications.

So, “there remains little mystery surrounding the health risks associated with arsenic levels in rice. The remaining mystery is why long-overdue standards for arsenic levels in rice have not been set by the FDA” in the United States, but that may be changing. In 2016, the FDA proposed setting a limit on toxic arsenic—at least in infant rice cereal, which I discuss in my video Arsenic in Infant Rice Cereal.

As you can see at 3:24 in my video, infants and children under four years of age average the highest rice intake, in part because they eat about three times the amount of food in relation to their body size, so there’s an especially “urgent need for regulatory limits” on toxic arsenic in baby food.

Pediatric nutrition authorities have recommended that when it comes to rice and rice-based products, “arsenic intake should be as low as possible,” but how about as early as possible? Approximately 90 percent of pregnant women eat rice, which may end up having “adverse health effects” on the baby.

You can estimate how much rice the mother ate while pregnant by analyzing arsenic levels in the infant’s toenail clippings. “Specifically, an increase of 1/4 cup of rice per day was associated with a 16.9% increase in infants toenail [arsenic] concentration,” which indicates that arsenic in rice can be passed along to the fetus. What might that arsenic do? A quarter cup of rice worth of arsenic has been associated with low birth weight, increased respiratory infections, and, above that, a 5- to 6-point reduction in IQ, among other issues. So, “based on the FDA’s findings, it would be prudent for pregnant women to consume a variety of foods, including varied grains (such as wheat, oats, and barley),” which is code for cut down on rice. Saying eat less of anything, after all, is bad for business.

Once the baby is weaning, “what’s a parent to do?” Asks Consumer Reports, “To reduce arsenic risks, we recommend that babies eat no more than 1 serving of infant rice cereal per day on average. And their diets should include cereals made of wheat, oatmeal, or corn grits, which contain significantly lower levels of arsenic”—that is, rely on other grains, which are much less contaminated than rice. As the American Academy of Pediatrics has emphasized, “there is no demonstrated benefit of rice cereal over those made with other grains such as oat, barley, and multigrain cereals, all of which have lower arsenic levels than rice cereal.” As you can see at 5:28 in my video, reducing consumption of infant rice cereal to just two servings per week could have an even more dramatic effect on reducing risk.

 The proposed limit on toxic arsenic in infant rice cereals would end up removing about half of the products off the shelves. The FDA analyzed more than 500 infant and toddler foods, and the highest levels of toxic arsenic were found in organic brown rice cereals and “Toddler Puffs.” Based on the wording in the report, these puffs appear to be from the Happy Baby brand. Not-so-happy baby if they suffer brain damage or grow up to get cancer. A single serving could expose infants to twice the tolerable arsenic intake set by the EPA for water. I contacted the Happy Baby company and was told they “are not able to provide any comments” on the FDA’s results.

“Eliminating all rice and rice products from the diets of infants and small children up to 6 years old could reduce the lifetime cancer risk from inorganic arsenic in rice and rice products by 6% and 23% respectively.” That is, there would be a 6 percent lower chance of developing lung or bladder cancer later in life if infants stopped, and a 23 percent lower chance if young kids stopped. However, switching to other grains is a move described as “drastic and dramatic,” creating “a huge crisis”—for the rice industry, presumably—and therefore “not feasible at all.”

I was hoping Happy Baby, upon learning of the concerning FDA arsenic toddler puffs data (regardless of whether the data were about its brand or not) would have kicked its own testing and potential remediation into high gear like Lundberg did (see Which Brands and Sources of Rice Have the Least Arsenic?). But, unfortunately, in my email correspondence with the company, I got no sense that it did.


For more videos on this topic, see:

And here are five more:

In health,

Michael Greger, M.D.

PS: If you haven’t yet, you can subscribe to my free videos here and watch my live presentations:

BMS calls time on brain cancer trial as Opdivo misses second target

Bristol Myers-Squibb has put out another downbeat “update” announcement about its immunotherapy Opdivo in an aggressive form of brain cancer, saying that it looks unlikely to produce a survival benefit in the disease.

BMS said an independent committee had reviewed data from the phase 3 CheckMate-548 trial in newly diagnosed MGMT-methylated glioblastoma multiforme and concluded that it would be unlikely to meet its primary overall survival (OS) goal.

The company already announced in September last year that the trial had missed its other primary endpoint of progression-free survival in all randomised patients.

There were no safety concerns that warranted stopping of the study, which will be unblinded to investigators following the announcement.

Patients will be advised on their treatment options, and those currently deriving benefit from Opdivo (nivolumab) are permitted to continue treatment if agreed to with their doctor.

After a complete evaluation of trial results, investigators will share final results with the oncology community.

CheckMate-548 is testing Opdivo plus current standard of care (temozolomide and radiation therapy) versus placebo plus standard of care, in patients with newly diagnosed GBM with MGMT promoter methylation.

The secondary endpoints are investigator assessed PFS, and OS rate at 12 and 24 months.

The news comes as former Celgene shareholders wait to see whether the FDA will approve a cancer cell therapy ahead of a deadline on New Year’s Eve.

Celgene shareholders were given a tradeable three-drug bet known as a Contingent Value Right (CVR) for every share they owned when the companies merged in November last year.

Three drugs need to be approved before certain deadlines for each CVR to pay out $9 – the MS drug Zeposia (ozaonimod) has already been met earlier this year.

The cancer cell therapy for lymphoma known as liso-cel must be approved by the FDA New Year’s Eve, followed by another CAR-T ide-cel on March 31 next year.

Both of these deadlines are under threat, with the FDA waiting on results from an outstanding factory inspection after the regulator delayed its review by three months by three months in May.

That inspection happened a few weeks ago and there renewed hopes the FDA will okay the drug in time for the deadline.

It will also be a close-run thing with multiple myeloma drug ide-cel, which has a decision date just four days before the final 31st March deadline.

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How to Cook Rice to Lower Arsenic Levels

Boiling rice like pasta reduces arsenic levels, but how much nutrition is lost?

Cooking rice in a high water-to-rice ratio reduces toxic arsenic content, which I discuss in my video How to Cook Rice to Lower Arsenic Levels. What exactly does that mean? Well, as you can see at 0:16 in my video, if you boil rice like pasta and then drain off the water at the end, you can drop arsenic levels in half—50 to 60 percent of the arsenic gets poured down the drain—whereas the typical way we make rice, boiling off the water in a rice cooker or pot, for example, doesn’t help. In fact, it may even make things worse if the water you’re using to cook the rice has arsenic in it, too, which is a problem that exists for about three million Americans, as about 8 percent of public water supplies exceed the current legal arsenic limits.

“Cooking rice in excess water”—and then discarding the excess water—“efficiently reduces the amount of inorganic As [that is, toxic arsenic] in the cooked rice,” but how much nutrition are you pouring down the drain when you do pour off the excess water?

“Unpolished brown rice naturally contains vitamins and minerals that are lost when the bran layer and germ are removed to make white rice. To compensate, since the 1940s polished white and parboiled rice sold in the United States is often enriched”—that is, white rice has had vitamins and minerals sprayed on it to so it’s “enriched” and “fortified.” That’s why cooking instructions for enriched white rice specifically say you shouldn’t rinse it and you should cook it in a minimal amount of water. In other words, you should do the opposite of what you’d do to get rid of some of the arsenic. But brown rice has the nutrients inside, not just sprayed on.

“Rinsing [white] rice,” by putting it in a colander under running water, for example, “removes much of the enriched vitamins sprayed onto the rice grain surface during manufacture,” removing most of the B-vitamins. But, “rinsing had almost no effect on vitamins in whole grain brown rice”—because brown rice has got the nutrition inside. It’s the same with iron: Rinsing white rice reduces iron levels by about three-fourths, but the iron in brown rice is actually in it, so rinsing only reduces the iron concentration in brown rice by about 10 percent. Rinsing didn’t seem to affect the arsenic levels, so why bother?

Well, if you really wash the rice, for example, agitating the uncooked rice in water, rinsing, and repeating for three minutes, you may be able to remove about 10 percent of the arsenic. So, one research team recommends washing rice as well as boiling it in excess water, but I don’t know if the 10 percent is worth the extra time it takes to wash the rice. However, as we discussed, boiling rice like pasta and then draining off the excess water does really cut way down on the arsenic, and, while that cooking method also takes a whack at the nutrition in white rice, the nutrient loss in brown rice is “significantly less,” as it is not so much enriched as it is rich in nutrition in the first place.

“Cooking brown rice in large amounts of excess water reduces the toxic arsenic by almost 60% and only reduces the iron content by 5%. It reduces the vitamin content of brown rice by about half,” however. You can see a graph of what I’m talking about at 3:18 in my video. A quick rinse of brown rice before you cook it doesn’t lower arsenic levels, but boiling it and draining off the excess water, instead of cooking to dry, drops arsenic levels by 40 percent. That was using about a ratio of 6 parts water to 1 part rice. What if you use even more water, boiling at 10-to-1 water-to-rice ratio? You get a 60 percent drop in arsenic levels.

With white rice, you can rinse off a little arsenic, but after cooking, you end up with similar final drops in arsenic content, but the iron gets wiped out in white rice by rinsing and cooking, whereas the iron in brown rice stays strong. There are similar decrements in the B vitamins with cooking for brown and unrinsed white rice, but once you rinse white rice, the B vitamins are mostly gone before they even make it into the pot.

What about percolating rice? Well, we know that regular rice cooking doesn’t help reduce arsenic levels, but boiling then draining rice like pasta does, while steaming doesn’t do much. What about percolating rice as a radical rethink to optimize arsenic removal? Researchers tried two types of percolating technology: One was a mad scientist-type lab set-up, and the other was just a regular off-the-shelf coffee percolator. Instead of putting in coffee, they put rice and percolated 20 minutes for white and 30 for brown. The result? As you can see at 4:39 in my video, they got about a 60 percent drop in arsenic levels using a 12-to-1 water-to-rice ratio. Raw brown rice started out at about double the arsenic levels of raw white rice, but, after cooking with enough excess water and draining, they end up much closer. Though, a 60 percent drop in arsenic levels by percolating at a 12-to-1 ratio was about what we got boiling at just 10-to-1. So, I don’t see a reason to buy a percolator.

But, what does that 60 percent drop really mean? By boiling and draining a daily serving of rice, we could cut excess cancer risk more than half from about 165 times the acceptable cancer risk to only about…66 times the acceptable risk.


At this point, I can imagine you thinking, Wait, so should we avoid rice or not? I’m getting there. First, I’m just laying out the issue. Here are videos on the latest on the topic, if you’re interested:

 And here are six more:

In health,

Michael Greger, M.D.

PS: If you haven’t yet, you can subscribe to my free videos here and watch my live presentations:

 

Agios’ cancer pipeline auction; uniQure’s gene therapy on hold; Ultragenyx, Mereo Deal; aTyr Pharma Trial

Servier Acquires Agios’ Cancer Portfolio in a USD 2 Billion Deal

The year is a prime witness of pricey deals and acquisitions in the pharmaceutical industry. To leave its mark, another player decided to hop onto the list. French drugmaker Servier has announced the acquisition of the Oncology business of Agios Pharmaceutical in a deal worth USD 2 billion. 

Parceled in the deal, besides Agios’ co-commercialization responsibilities for Bristol Myers Squibb’s Idhifa (enasidenib), Servier announced, are Agios’ oral leukemia treatment Tibsovo, vorasidenib, AG-270, and AG-636. Tibsovo approved for relapsed or refractory acute myeloid leukemia (R/R AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation, is presently under investigation in two Phase III combination trials in newly diagnosed AML, and as a potential treatment for previously treated IDH1-mutant cholangiocarcinoma and IDH1-mutant myelodysplastic syndrome (MDS). Vorasidenib is an investigational, brain-penetrant, dual inhibitor of mutant IDH1 and IDH2 in a Phase III trial in patients with IDH-mutant low-grade glioma, AG-270 is an investigational first-in-class methionine adenosyltransferase 2a (MAT2A) inhibitor while AG-636 is a novel inhibitor of dihydroorotate dehydrogenase.

The acquisition will help Servier bolster its presence in the oncology market. As per the company, the decision further pushes a step ahead towards its aims to become a “recognized and innovative player” in oncology for which Servier has allocated 50% of its overall R&D budget. After the news broke, shares of Agios soared in premarket trading.

FDA Puts uniQure’s Hemophilia B Gene Therapy on Leash

The fate of drugs, even if the drug appears invincible, remains unpredictable unless it passes from the eyes of almighty the USFDA. In a recent, uniQure faced backlash after its hemophilia B gene therapy got hit with clinical hold by the USFDA. 

Recently, the company announced at ASH (American Society of Hematology’s annual meeting) that its Phase III HOPE-B study has been put on hold owing to the submission of a safety report in mid-December that unveiled the case of an enrolled patient (dosed over a year ago) developing hepatocellular carcinoma (HCC), a form of liver cancer. Although, the company believes that in no way the gene therapy could have caused HCC, and the outcome in this particular situation is due to him being at high risk for liver cancer with a long history of hepatitis C, hepatitis B virus, findings of non-alcoholic fatty liver disease and advanced age.

The trial was investigating etranacogene dezaparvovec (AMT-061). It substantially increased the production of the blood-clotting protein factor IX, which is the factor missing for hemophilia B patients, in all the enrolled patients. The Hemophilia B market has several therapies, however, no therapy has been able to kill the disease from its root. Although, stumble-prone, gene therapies offer a bright leeway to target these diseases, where the company was taking its chances. However, there lies still hope as the clinical hold, it seems, will not affect the pivotal trial results as the dosing of the patients is completed.

Ultragenyx Pharmaceutical Teams up with Mereo BioPharma for a Bone Disease Candidate

Ultragenyx (RARE) and Mereo collaborated to develop and commercialize setrusumab, a monoclonal antibody for a rare genetic disorder osteogenesis imperfecta (OI). It is a heritable disorder of bone formation resulting in low bone mass and an increased propensity to fracture.

A Phase IIb study – ASTEROID – which tested setrusumab in 90 adults with OI types I, III, and IV across three dose groups for 12 months, demonstrated improvements in bone mineral density at several anatomical sites on a dose-dependent basis. The company also mentioned that the drug is able to reduce the fractures at the highest dose as compared to lower ones. 

As per the deal, Ultragenyx is paying USD50 million upfront along with up to USD254 million in milestones payments. It will undertake the development of the drug as well as its marketing worldwide (except for Europe, where Mereo has the marketing rights).

aTyr Pharma Completes Enrollment in Phase 1b/2a Pulmonary Sarcoidosis Clinical Trial Testing ATYR1923 

aTyr Pharma announced that the company has completed the target enrollment of 36 patients in its Phase 1b/2a clinical trial aimed at evaluating its lead candidate, ATYR1923, for pulmonary sarcoidosis, a form of interstitial lung disease (ILD). 

Sarcoidosis is a rare condition that leads to the development of small patches of red and swollen tissue, called granulomas in the organs, usually affecting the lungs and skin. Sarcoidosis in the lungs is called Pulmonary Sarcoidosis. The present treatment regimen for this multisystem disorder is to prevent or control organ damage, relieve symptoms, and improve the patient’s quality of life.

aTyr Pharma’s ATYR1923 works by selectively modulating NRP2 to downregulate the innate and adaptive immune response in inflammatory disease states and is in undergoing trial. The company plans to report data from this trial in the third quarter of 2021. 

The post Agios’ cancer pipeline auction; uniQure’s gene therapy on hold; Ultragenyx, Mereo Deal; aTyr Pharma Trial appeared first on DelveInsight Business Research.

AZ’s Tagrisso gets new early lung cancer use in US

AstraZeneca’s Tagrisso (osimertinib) has been approved by the FDA in a new lung cancer indication that extends its use to a group of patients with early-stage disease.

The new use covers adjuvant treatment of adult patients with early-stage epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after a potentially curative operation.

Patients must be tested to for the presence of the mutation to check they are eligible to receive the oral drug.

Up to 30% of all patients with NSCLC may be diagnosed early enough to have potentially curative surgery.

But disease recurrence is still common in early-stage disease and nearly half of patients diagnosed in Stage IB, and over three quarters of patients diagnosed in Stage IIIA, experience recurrence within five years.

Based on the findings of the phase 3 ADAURA study this could change, as Tagrisso demonstrated a statistically significant and clinically meaningful improvement in disease-free survival in a primary analysis of patients with Stage II and Stage IIIa NSCLC with EGFR mutations.

This was also seen in the overall trial population of patients with Stage 1B-IIIA disease, the secondary endpoint of the trial.

Findings showed that Tagrisso cut the risk of disease recurrence by 83% compared with placebo in the trial that was stopped early because of the high efficacy shown in the treatment arm.

The ADAURA results were showcased as the last set presentation at this year’s virtual American Society of Clinical Oncology conference, rather like the headline performer at a rock festival.

Results dazzled the oncologists who described the findings as a “home run” and the new indication will also have beneficial side-effect on AZ’s finances, adding substantially to the blockbuster revenues already generated by Tagrisso.

The results also suggest further uses for the drug in early disease and more revenues to come from one of the company’s biggest success stories from the last decade.

Tagrisso was first approved in 2015 to counter a single amino acid mutation known as T790M that nearly always occurs after about 10 months of treatment with tyrosine kinase inhibitor drugs, making tumours resistant.

But after approval in later stage disease, AZ found that the drug outperforms rival tyrosine kinase inhibitors as a first-line treatment in the FLAURA trial, leading to a second FDA indication two years ago.

Tagrisso is already a blockbuster bringing in revenues of more than $3.1 billion in the first nine months of this year, and the new indication will add further momentum to AZ’s biggest selling drug.

 

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MacroGenics’ HER2 breast cancer drug Margenza approved in US

MacroGenics’ HER2-targeted breast cancer drug Margenza has been approved by the FDA, challenging several recently approved drugs with a narrow efficacy edge over Roche’s Herceptin in data gathered so far in advanced disease.

Margenza (margetuximab) won FDA approval in combination with chemotherapy to treat metastatic HER2-positive breast cancer after at least two previous rounds of therapy.

One of the talking points at the American Society of Clinical Oncology (ASCO) in 2019, Margenza is a tweaked version of Roche’s Herceptin (trastuzumab), which dominated the HER2-mutated breast cancer market for years until the recent launch of cut-price biosimilar competitors.

MacroGenics has altered the “Fc” part of the antibody – the tail of the ‘Y’-shaped molecule – so that it interacts more efficiently with the immune system when engaged with a cancer cell.

This has produced a small but significant benefit in progression-free survival, with the phase 3 SOPHIA study showing a 24% reduction in the risk of disease progression or death with Margenza plus chemotherapy, compared with trastuzumab plus chemo.

The median progression-free survival (PFS) of patients treated with Margenza and chemotherapy was 5.8 months compared to 4.9 months in patients treated with trastuzumab and chemotherapy.

The difference was more marked in patients carrying a genetic variation called CD16A 158F, where PFS was prolonged by 1.8 months in the margetuximab arm compared to the trastuzumab arm (6.9 months versus 5.1 months).

Response rate was also improved with the Margenza regimen at 22%, compared with 16% in those treated with the Herceptin regimen.

A final overall survival analysis is expected in the second half of 2021, after a planned launch in March next year.

No price has been officially decided but the company said it plans to price it at the low end of the price range seen in other HER2 metastatic breast cancer therapies.

Those competing therapies include Seagen’s Tukysa (tucatinib), which was approved in May for advanced HER2-positive disease in combination with trastuzumab and capecitabine after treatment with at least one HER2-targeted drug.

AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) was approved a year ago for HER2-positive breast cancer after two or more previous HER2 regimens and Puma’s Nerlynx (neratinib) is another FDA-backed option in this indication.

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Amgen files KRAS trailblazer sotorasib with FDA for lung cancer

Amgen has filed its groundbreaking KRAS inhibiting drug sotorasib with the FDA for a group of lung cancer patients with an aggressive form of the disease.

The drug was the first targeted at the mutation known as KRAS to show activity in the clinic and provided the biggest talking point at the American Society of Clinical Oncology (ASCO) conference in 2019.

Since then Amgen has been gathering evidence to support a filing in a group of patients with advanced or metastatic KRAS G12C mutated non-small cell lung cancer.

The FDA is reviewing sotorasib under its Real-Time Oncology Review (RTOR) programme and could be the first to be approved in this indication, which covers around 13% of NSCLC patients.

Amgen’s filing is on track with a schedule laid out at the beginning of the year, following a top-line read out from a phase 2 trial in October.

These results came from the CodeBreaK 100 clinical study, which tested the drug in patients whose cancer had progressed despite prior treatment with chemotherapy and/or immunotherapy.

In the study, treatment with sotorasib provided durable anticancer activity with a positive benefit-risk profile, Amgen said, although detailed results have yet to be announced.

Full results will be presented at the International Association for the Study of Lung Cancer (IASLC) 2020 World Conference on Lung Cancer (WCLC) Presidential Symposium next month.

KRAS is a target that has long evaded pharma companies but early trial results in solid tumours at ASCO led to a round of deal-making involving rivals.

Mirati, a biotech from California, specialises in drugs targeting KRAS and is a step behind Amgen with its rival adagrasib.

Novartis signed a deal to evaluate Mirati’s drug soon after ASCO and Merck & Co and Boehringer Ingelheim are among those who have signed KRAS deals.

Although it looks like the molecules developed so far will work only in lung cancer, rather than the wider range of cancers with KRAS mutations, there is hope the drug will provide a new treatment option for an aggressive and deadly form of the disease.

David Reese, executive vice president of Research and Development at Amgen, said: “Sotorasib was the first KRASG12C inhibitor to enter the clinic and now is on track to potentially be the first approved targeted therapy for patients with advanced NSCLC harbouring the KRAS G12C mutation.”

The post Amgen files KRAS trailblazer sotorasib with FDA for lung cancer appeared first on .

COVID-19 and Reductions in Cancer Mortality

That is the topic of a commentary I wrote with co-authors Joanna MacEwan and Farzad Ali, titled “Does COVID-19 Threaten the Progress Pharmaceuticals Have Made in Reducing Cancer Mortality Over the Last 20 Years?” An excerpt is below:

Cancer mortality rates have fallen significantly over the last 20 years. Between 2000 and 2010, overall age-adjusted cancer mortality rates decreased by about 1% per year globally.1 In the United States, the trend has been equally pronounced. Overall, the US cancer mortality rate declined by 29% between 1991 and 2017, translating into an estimated 2.9 million fewer cancer deaths.2 Notably, cancer mortality rates fell by 2.2% between 2016 and 2017, the sharpest single-year drop on record.2 
This leaves us with 2 key questions: what factors are the primary causes of the reduction in cancer mortality, and does COVID-19 threaten to stall this progress?3 

We discuss the role of pharmaceuticals in this decline in cancer mortality and what can be done to insure cancer mortality continues to fall even during the COVID-19 pandemic.

Readers and Tweeters Defend Front-Line Nurses and Blind Us With Science

Letters to the Editor is a periodic feature. We welcome all comments and will publish a selection. We edit for length and clarity and require full names.

The demand for skilled nurses during the pandemic is through the roof! Travel nurses command a hefty salary and they are worth every penny… #COVID19 #pandemic #RN https://t.co/gYQpkHqaoX

— Talmage Egan, MD (@UofU_Anes_Chair) November 26, 2020

— Dr. Talmage Egan, Salt Lake City

Nurses Deserve to Be Paid Handsomely

I read your article “Need a COVID-19 Nurse? That’ll Be $8,000 a Week” (Nov. 24) in the Springfield Journal-Register. It was an interesting article as I have a daughter who is a nurse. Nurses have been underpaid and unappreciated for years. It made me angry that the article characterized the wages some hospitals are willing to pay for nurses as exorbitant. Hogwash if you think someone should risk their life every hour of the day to care for COVID patients without proper compensation. How many doctors make over a million a year? You don’t cite that as unusual. I feel that nurses should go for the gold as they have been taken advantage of for years and, too bad, but good for them. Choose your words more carefully in the future. Nurses ROCK!!!!

— Mike Booher, Lincoln, Illinois

Hospitals go out of their way to avoid competing for nursing labor by raising wages. Now hospital executives and public health advocates act like it’s a travesty that COVID nurses are finally getting paid market rates to take on risky jobs. https://t.co/6z0idToVn6

— Devon M. Herrick (@DevonHerrick) November 24, 2020

— Devon M. Herrick, Dallas

Missing in the Mix of Vaccine Coverage

I must note two important omissions in the article “Time to Discuss Potentially Unpleasant Side Effects of COVID Shots? Scientists Say Yes” (Nov. 12). First, although these were interim trial results, the placebo arm should also have been reported out. What was the placebo infection rate? Reporting 90% effectiveness is irrelevant without reporting the placebo rate simultaneously. And one needs to align the infection rate in trial subjects with the incidence of disease in the U.S. population. They should be similar, but if not, any discrepancy must be explained (such as, no elderly people or children participating in the trial). Secondly, and perhaps more important: What other mitigating measures were volunteers in this trial required/advised to take? For example, physical distancing, masks, etc. I could find no mention of this, positively or negatively, when reading the protocol on clinicaltrials.gov. Any vaccine alone could not provide 94.5% efficacy. To determine the relative contributions of other measures, you’d need, say, a four-arm study — placebo with mask, placebo without mask, vaccine with mask, vaccine without mask. Statistically and clinically, one must account for other variables that may confound an apparent result.

This is a crucial point as the lay public is thinking that, by getting the vaccine, masks might no longer be necessary and they’ll have a 95% chance of not being infected. This is rubbish. The media and the public “experts” need to address this as they are setting themselves up for an immense PR failure and still greater skepticism. People may need to wear masks for many more months, maybe years, even with an effective vaccine.

— Stephen Zaruby, Truckee, California

I’m already confused 😕 https://t.co/UlJPh2EEvK

— hameen tariq (@hameentariq) November 23, 2020

— Hameen Tariq, Wilmington, Delaware

Exploring Cancer Drug’s Effects on COVID

Your story “Clots, Strokes and Rashes: Is COVID a Disease of the Blood Vessels?” (Nov. 13) was reprinted in my local newspaper. My brother, James L. Kinsella Ph.D., led the original work at the National Institutes of Health researching how the chemotherapy drug Taxol could reduce inflammation in coronary articles following the placement of coronary stents. This led to the very effective use of drug-eluting coronary stents. My unprofessional musing causes me to wonder if this anti-inflammatory response to Taxol might have some application as an early therapeutic intervention to reduce the inflammatory response of COVID-19 being studied by Dr. William Li. I can’t ask my brother; he passed away.

— Rick Kinsella, Oneida, New York

He wouldn’t be dead without covid. We’ve learned that things that aren’t life threatening are made life threatening by this disease. It attacks your blood vessels so it can exacerbate anything anywhere in your body that uses blood vessels. Stay safe indeed https://t.co/BFsqrKSFmH

— James McPicnic (@WhiteRatbit) December 3, 2020

— James “J.P.” McPicnic, Los Angeles

Women’s Health Should Not Be Up for Debate

Birth control medication is so much more than a pawn in politics (“Coming Abortion Fight Could Threaten Birth Control, Too,” Nov. 5). It changes the lives of so many women for the better. Birth control access has been proven to lead to higher rates of education for women, lower levels of child poverty, lower Medicaid costs for women’s health and higher productivity of society as a whole. It also treats a large number of medical conditions associated with women’s health. It effectively treats severe menstrual migraines, hormonal acne, endometriosis, severe menstrual pain, uterine abnormalities, anemia and heavy menstrual bleeding, among other health conditions. This medication is involved in treating so many women’s health concerns, improves infant and child health outcomes, and reduces child poverty, and yet almost 20 million women in the U.S. currently have no access to birth control medication. American politicians need to consider, if nothing else, the spillover costs to society when birth control access is reduced.

Women’s reproductive health should not be up for debate and yet it is at the center of so many political agendas. As a 24-year-old woman pursuing dual master’s degrees in public health and physician assistant studies, my focus should be on learning to become an exceptional health care provider, not whether my health will be up for debate in court. If politicians truly have the best interests of Americans at heart, they should be looking to expand birth control access, not restrict it.  Evidence needs to be incorporated into political agendas, and the evidence shows that when women succeed, society succeeds. Women’s education, health and reproductive rights should be at the forefront of every discussion on what constitutes a thriving population — the evidence has proven that women’s autonomy holds the answer and access to birth control is a vital piece of that.

— Gabby Henshue, Madison, Wisconsin

Scary times for women’s bodies.

“States could effectively ban contraception by arguing that some contraceptives act as abortifacients.” Threat is real. I’ve worked in states where this argument has been made.https://t.co/LmdWFRUNOZ

— Elizabeth M. Baskett (@EMBaskett) November 11, 2020

— Elizabeth M. Baskett, Denver

Injustice in High Gear

I was appalled at the charges on the medical bill from the Carson City emergency department for that child who fell off his bike (“Bill of the Month: After Kid’s Minor Bike Accident, Major Bill Sets Legal Wheels in Motion,” Nov. 25) — $18,000 for an exam and stitches? What would it take to sort out such problems in our health system? Lower prices from providers could only result in lower insurance premiums.

— Karen Johnson, San Rafael, California

Attempted subrogation, man, I tell yah https://t.co/spxcMlSiCk

— Annie M. Davidson (@attyannie) November 25, 2020

— Annie M. Davidson, St. Paul, Minnesota

KHN Morning Briefing: A Wealth of Information in One Spot!

I just wanted to say it is awesome to have portions of articles from many major news outlets because never does one tell the whole story. Case in point: I was trying to research what exactly President Donald Trump had done that “allowed doctors to discriminate against LGBT people,” and it was very helpful having a wide array of media sources on a single page to help get the bigger picture and try and weed through the bias of all of them (“Trump Administration’s Expanded Conscience Rule Will Allow Medical Professionals To Refuse To Provide Health Care Services,” May 3). Just sending my compliments. Keep up the great work.

— Nolan Steeley, Greensburg, Pennsylvania

💥Racism in #healthcare undermines #quality of care and patient safety. There’s hard work to be done to weed it out of all parts of society, especially clinical care. https://t.co/TbK0yIuraB

— Natalie S. Burke (@natalie4health) November 28, 2020

— Natalie S. Burke, Washington, D.C.

Education and Coverage Gaps Lead to Avoidable Amputations 

Coming to terms with systemic racism in health care is long overdue (“What Doctors Aren’t Always Taught: How to Spot Racism in Health Care,” Nov. 17). The way medicine is taught and the payment policies that shape the system have created persistent disparities in patient outcomes across racial and ethnic groups.

As a result, Black Americans are 80% more likely than whites to be diagnosed with diabetes and are twice as likely to die from the disease. Furthermore, Black American patients are up to four times more likely to experience an amputation than their white counterparts due to advanced peripheral artery disease (PAD), a common complication for people with diabetes and other chronic conditions. Similarly, Latinos are up to 75% more likely to experience an amputation than whites, while Native Americans are twice as likely to lose a limb.

As many as 85% of the nation’s 200,000 non-traumatic amputations could be prevented with access to screening and early detection. By screening for PAD through non-invasive arterial testing, the likelihood of an individual needing a PAD-related amputation can be reduced by up to 90%. Unfortunately, too few Americans — particularly racial and ethnic minorities — are even offered routine screening for PAD due to a widespread lack of understanding about the disease, as well as structural coverage barriers to simple, painless tests. As a result, many do not even know they have the disease until it is too late to save their limbs.

Communities of color deserve better. Members of the Congressional PAD Caucus — led by Rep. Donald Payne Jr. (D-N.J.) — recently introduced the Amputation Reduction and Compassion (ARC) Act to establish an education program about the disease — particularly for high-risk populations — and update reimbursement policy to disallow payment for non-emergent amputations unless arterial testing has been done in the three months before amputation. These simple solutions have the power to prevent thousands of avoidable amputations, and begin to correct health disparities in minority communities.

While we still have a long way to go as our country continues to grapple with systemic racism in health care, the ARC Act represents an important step toward ending disparities in PAD care.

— Dr. Foluso Fakorede, CEO of Cardiovascular Solutions of Central Mississippi, Cleveland, Mississippi

Racism in Health Care? Another example of injecting Politics. Inarguably, racism exists everywhere, but to make this a big issue is a disservice. Diff DX requires inclusion of Race/Ethnicity, to wit: Sickle Cell in Blacks,Alpha & Beta Thalassemia in Asians https://t.co/xyP54dPjH8

— Alexander R. Lim, MD (@AlexanderLim13) November 25, 2020

— Dr. Alexander R. Lim, Corpus Christi, Texas

‘Obamacare’ Unfairly Politicizes Health Law

I found this article interesting (“Biden Plan to Lower Medicare Eligibility Age to 60 Faces Hostility From Hospitals,” Nov. 11) but was surprised that the Affordable Care Act was referred to as “Obamacare.” Please don’t politicize the ACA — we really need it to continue allowing people to access health care. Many people do not have health care through their workplace and are unable to afford private insurance premiums. I was once one of those people before I was hired at our local library. It was really tough. Thank you for your reporting.

— Pamela Elicker, Port Townsend, Washington

Putting People First on the Podcast

When you were talking about drug policy and the ballot in a recent podcast (“KHN’s ‘What the Health?’: Change Is in the Air,” Nov. 6), you used terms that are considered incorrect or stigmatizing. For example, saying “opioid epidemic” when it’s really a crisis and referring to substance use as “abuse.” The Associated Press and NPR, among others, have pledged to use people-first language, as also supported by the American Psychological Association.

— Deirdre Dingman, Philadelphia

The Backbone of the Insurance Industry

It’s disingenuous to assert that people “can’t always rely on insurance brokers to give them accurate information or steer them to comprehensive coverage” based on the unfortunate experience of one consumer with a short-term health plan, as Michelle Andrews did in the article “Think Your Health Care Is Covered? Beware of the ‘Junk’ Insurance Plan” (Dec. 4).

Agents and brokers are crucial to our nation’s efforts to get people covered. This year, they assisted almost half of all healthcare.gov enrollees — and brought 1.12 million new enrollees into the marketplace. It’s no wonder that a new report from the Centers for Medicare & Medicaid Services has called agents and brokers “instrumental in driving greater participation in the individual health insurance market.”

Further, agents and brokers have long maintained that short-term plans are not appropriate substitutes for comprehensive exchange coverage. We at the National Association of Health Underwriters stated as much in official comments filed with the Trump administration before it finalized a rule extending the duration of short-term plans to 12 months.

— Janet Trautwein, CEO of the National Association of Health Underwriters, Washington, D.C.

 


Not Tickling My Funny Bone

You ought to find some cartoonists who are not so flagrantly left-leaning — continuing to provide left-sided commentary is not right. It’s like all of the news stations pushing for socialism.

— Harry Gousha, Upland, California

Editor’s note: It is the tradition and mission among editorial cartoonists to satirize those in power. As with the nation’s leadership, the targets of political cartoons toggle from right to left. Balance is not these artists’ goal, but over time their commentary balances out. Stick with us, and we hope to amuse you in the future.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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Which Rice Has the Least Amount of Arsenic: Black, Brown, Red, White, or Wild?

Brown rice contains more arsenic than white rice, but the arsenic in brown rice is less absorbable, so how does it wash out when you compare the urine arsenic levels of white-rice eaters to brown-rice eaters?

Arsenic in rice is a cause for concern, according to a consensus statement by the European and North American societies for pediatric nutrition. At the very least, “in areas of the world where rice consumption is high in all ages, authorities should be prompted to declare which of the rice [types] have the lowest arsenic content and are, therefore, the least harmful for use during infancy and childhood.” I look into the arsenic content of different rices in my video Which Rice Has Less Arsenic: Black, Brown, Red, White, or Wild?.

Extensive recent testing by the FDA found that long grain white rice, which is what most people eat, appears to have more arsenic than medium or short grain rice, but this may be because most of the shorter grains are produced in California, which has significantly less contaminated rice paddies than those in the South, such as in Texas or Arkansas, where most of the long grain rice is grown. So, it’s less long grain versus short grain than white rice versus brown rice, as the mean concentration of inorganic arsenic in parts per billion of long grain white rice is 102.0 and 156.5 in short, medium, and long grain brown rice, as you can see at 0:54 in my video.

What about some of the naturally pigmented varieties like red rice or black rice, which may be even healthier than brown? As you can see at 1:08 in my video, they may contain even less arsenic than white rice. One sample of black rice from China that was purchased in Kuwait had higher levels for total arsenic, so the toxic inorganic portion may only be half that, putting it on par with U.S. brown rice. The study’s red rice sample from Sri Lanka was even more extraordinary, with less than a fifth of the arsenic of the Chinese black rice. But, the Sri Lankan red rice sample had a ridiculous high amount of cadmium, evidently attributed to the cadmium content of widely used Sri Lankan fertilizers.

Colored rice samples purchased mostly in the United States were better than brown or white, and a dozen samples of red rice purchased in Europe were as bad, or even worse, as brown rice. I was hoping that wild rice would have little or no arsenic because it’s a totally different plant, but an average of eight samples showed it to be nearly comparable to white, though the wild rice samples contained only half as much toxic arsenic as brown rice.

As you can see at 2:06 in my video, the arsenic found in a daily serving of white rice carries 136 times the acceptable cancer risk, but brown rice is even riskier at 162. Brown rice averages two-thirds more toxic arsenic than white rice. But, is that just because brown rice tends to be a different strain or grown in different places? No. If you take the exact same batch of brown rice and measure the arsenic levels before and after polishing it to white, you do get a significant drop in arsenic content.

It’s not what you eat, though. It’s what you absorb. The arsenic in brown rice appears to be less bioavailable than the arsenic in white rice. The texture of brown rice may cut down on the release of arsenic from the grain, or perhaps the bran in brown rice helps bind it up. Regardless, taking bioavailability into account, the difference in arsenic levels in white versus brown rice may be a third more, rather than 70 percent more, as you can see at 2:57 in my video. This estimate, however, was based on an in vitro gastrointestinal fluid system in which researchers strung together beakers and tubes to mimic our gut, with one flask containing stomach acid and another intestinal juices. What happened when it was tested in humans? Yes, “evidence suggests that brown rice may contain more arsenic than white rice,” but the researchers aimed to determine how much is actually absorbed by measuring the urine levels of arsenic in white-rice eaters compared with brown-rice eaters. For the arsenic to get from the rice into your bladder, it has to be absorbed through your gut into your bloodstream.

As you can see at 3:45 in my video, the urine of thousands of American test subjects who don’t eat rice at all still contains about 8 micrograms of toxic, carcinogenic arsenic a day. It’s in the air, it’s in the water, and there’s a little bit in nearly all foods. But, eat just one food—a cup or more of white rice a day—and your arsenic exposure shoots up by 65 percent to about 13 micrograms a day.

What about those who eat a cup or more of brown rice every day, which technically contains even more arsenic? Their exposure shoots up the same 65 percent. There is no difference between the urine arsenic levels of white-rice eaters compared with brown-rice eaters. However, this was not an interventional study in which they fed people the same amount of rice to see what happened, which would have been ideal. Instead, it was a population study, so maybe the reason the levels are the same is that white-rice eaters eat more rice than do brown-rice eaters. Could that be why they ended up with the same levels? We don’t know, but it should help to put the minds of brown-rice eaters to rest. But would it be better to eat no rice at all? That’s what I’ll explore in my next few blogs.


 If you’re just joining in on this topic, check out these lead-up videos:

 

It seems like each of these videos just raises more questions, but don’t worry because I’ve got answers for you. See:

In health,

Michael Greger, M.D.

PS: If you haven’t yet, you can subscribe to my free videos here and watch my live presentations:

 

Report: More than 1,300 medicines and vaccines in development to help fight cancer

Over the last 30 years, significant progress has been made in the fight against cancer. Researchers have expanded their understanding of how cancer develops and how to target medicines for specific cancer types. Since peaking in 1991, the death rate associated with cancer declined by 29%, which translates to 2.9 million fewer cancer deaths. The most recent data shows that between 2016 and 2017 alone, cancer death rates declined by 2.2%, the largest single-year drop ever recorded. Despite the challenges imposed by the COVID-19 pandemic, this momentum continues with biopharmaceutical companies focusing on research and development of innovative cancer therapies.

Roche Launches Cobas PIK3CA Mutation Test for Patients with Advanced or Metastatic Breast Cancer

Shots:

  • Roche launches the cobas PIK3CA mutation test for patients with advanced/ m-BC in countries accepting the CE mark
  • The IVT test is a real-time PCR test for the qualitative detection & identification of 17 mutations in exons 2, 5, 8, 10 & 21 in the gene encoding the catalytic subunit of PIK3CA in DNA isolated from FFPET and is intended to identify patients with m-BC harboring mutations
  • This test reports automated results, with flexible throughput to process 30 samples/ run on the widely available cobas z 480 analyzers. The test can detect 17 mutations in the PIK3CA gene and can help clinicians to identify patients who may benefit from PI3K targeted therapy

Click here ­to­ read full press release/ article | Ref: GlobeNewswire | Image: Handelsblatt

The post Roche Launches Cobas PIK3CA Mutation Test for Patients with Advanced or Metastatic Breast Cancer first appeared on PharmaShots.

5 big healthcare lawsuits of 2020

Some of the biggest legal stories of the year include patients attempting to mount a class action lawsuit against Mayo Clinic after an employee improperly viewed more than 1,600 health records and the Supreme Court hearing opening arguments in a case challenging the constitutionality of the ACA’s individual mandate.

Daiichi Sankyo and AZ’s Trastuzumab Deruxtecan Receives CHMP’s Recommendation for Approval to Treat HER2 Positive Metastatic Breast Cancer

Shots:

  • The recommendation is based on a P-II DESTINY-Breast01 study assessing trastuzumab deruxtecan in patients with HER2 positive unresectable/ m-BC prior treated with trastuzumab emtansine
  • The trial demonstrated a meaningful & durable activity in patients who had received two or more prior anti-HER2 therapies. The safety & tolerability profile of the therapy was consistent with the P-I trial
  • EC will review the CHMP’s positive opinion to grant MAA for the therapy in the EU. Trastuzumab deruxtecan is a HER2 directed ADC

Click here ­to­ read full press release/ article | Ref: Business wire | Image: GlassDoor

The post Daiichi Sankyo and AZ’s Trastuzumab Deruxtecan Receives CHMP’s Recommendation for Approval to Treat HER2 Positive Metastatic Breast Cancer first appeared on PharmaShots.

LeenTaaS Secures $130M for ML Platform to Help Hospitals Achieve Operational Excellence

LeenTaaS Secures $130M for ML Platform to Help Hospitals Achieve Operational Excellence

What You Should Know:

LeanTaaS
raises $130 million in Series D Funding to strengthen its machine learning platform
to continue helping hospitals achieve operational excellence during a time
where they are facing mounting financial pressures due to COVID-19. 

– LeanTaaS provides software solutions that combine lean
principles, predictive analytics, and machine learning to transform hospital
and infusion center operations to improve operational efficiencies, increase
access, and reduce costs.

– LeanTaaS’ solutions have now been deployed in more than
300 hospitals across the U.S., including five of the 10 largest health networks
and 12 of the top 20 hospitals in the U.S.


 LeanTaaS, Inc., a
Silicon Valley software innovator that increases patient access and transforms
operational performance for healthcare providers, today announced a $130
million Series D funding round led by
Insight Partners
with participation from Goldman Sachs. With this
investment, LeanTaaS has raised more than $250 million in aggregate, including
more than $150 million from Insight Partners. As part of the transaction,
Insight Partners’ Jeff Horing and Jon Rosenbaum and Goldman Sachs’ Antoine
Munfa will join LeanTaaS’ Board of Directors.

Lean + Predictive Analytics = Operational Excellence

LeenTaaS Secures $130M for ML Platform to Help Hospitals Achieve Operational Excellence

Healthcare reform, an aging population, and a higher
incidence of chronic disease has caused the demand for healthcare services to
escalate quickly. At the same time, pressure from payers to eliminate waste
requires that healthcare providers do more with less to meet this skyrocketing
demand with the resources in which they have already invested. And this
situation is only going to get worse.

As more healthcare data gets digitized, the opportunity exists to leverage that data to help providers meet these challenges and more efficiently match supply and demand. Founded in 2010, LeanTaaS believes hospitals should use objective data and predictive analytics – not intuition and “tribal rules”– to better match resource supply with demand and to amplify the business impact of investments they have already made in EHR, BI, and Lean/Six Sigma.

Better Healthcare Through Math

LeenTaaS Secures $130M for ML Platform to Help Hospitals Achieve Operational Excellence

LeanTaaS develops software that increases patient access to
medical care by optimizing how health systems use expensive, constrained
resources like infusion chairs, operating rooms, and inpatient beds. More than
100 health systems and 300 hospitals – including 5 of the 10 largest systems,
12 of US News and World Report’s top 20 hospitals. These hospitals use the iQueue
platform to optimize capacity utilization in infusion centers, operating rooms,
and inpatient beds. iQueue for
Infusion Centers
is used by 7,500+ chairs across 300+ infusion centers
including 70 percent of the National
Comprehensive Cancer Network
 and more than 50 percent of National Cancer Institute hospitals. iQueue for
Operating Rooms
is used by more than 1,750 ORs across 34 health systems to
perform more surgical cases during business hours, increase competitiveness in
the marketplace, and improve the patient experience.

Related: How
Hospitals Can Create Better Inpatient Bed Capacity Through Math

Expansion Plans

The funds will be used to invest in building out the existing suite of products (iQueue for Operating Rooms, iQueue for Infusion Centers, and iQueue for Inpatient Beds) as well as scaling the engineering, product, and go to market teams, and expanding the iQueue platform to include new products. 

“LeanTaaS is uniquely positioned to help hospitals and health systems across the country face the mounting operational and financial pressures exacerbated by the coronavirus. This funding will allow us to continue to grow and expand our impact while helping healthcare organizations deliver better care at a lower cost,” said Mohan Giridharadas, founder and CEO of LeanTaaS. “Our company momentum over the past several years – including greater than 50% revenue growth in 2020 and negative churn despite a difficult macro environment – reflects the increasing demand for scalable predictive analytics solutions that optimize how health systems increase operational utilization and efficiency. It also highlights how we’ve been able to develop and maintain deep partnerships with 100+ health systems and 300+ hospitals in order to keep them resilient and agile in the face of uncertain demand and supply conditions.”

Chief Marketing Officer Appointment

Concurrent with the funding, LeanTaaS announced that Niloy Sanyal, the former CMO at Omnicell and GE Digital, would be joining as its new Chief Marketing Officer. Also, Sanjeev Agrawal has been designated as LeanTaaS’ Chief Operating Officer in addition to his current role as the President. “We are excited to welcome Niloy to LeanTaaS. His breadth and depth of experience will help us accelerate our growth as the industry evolves to a more data-driven way of making decisions” said Agrawal.

Pair Team Emerges Out of Stealth with $2.7M to Automate Primary Care Operations

Pair Team Emerges Out of Stealth with $2.7M to Automate Primary Care Operations

What You Should Know:

– San Francisco-based digital health startup Pair Team
emerges out of stealth with $2.7M in seed funding backed by Kleiner Perkins,
Craft Ventures, & YC.

– Pair Team provides both a remote team and AI that automates workflows, provides infrastructure & improves medical practices — efficiencies and billing as you’d expect, but all driving toward value-based, quality patient care.

– Pair’s wrap-around technology tripled the rate of annual wellness visits and increased revenue by 15% for clinics in 2020.


Pair Team (“Pair”) announced today it has
emerged out of stealth and has raised $2.7 million in seed funding backed by Kleiner Perkins, Craft Ventures, and YCombinator, along with other prominent
funds. Pair is an end-to-end operations platform for value-based primary care,
backed by Pair’s own care team. For patients, Pair provides a digital front door
and helps them navigate healthcare.

Automate Primary Care Operations Infrastructure

Founded in 2019 by Neil Batlivala and Cassie Choi, RN after experiencing how critical a high functioning administrative team is to provide high-quality primary care by building out operations together at leading tech-enabled practices of Forward and Circle Medical. The majority of healthcare is local and fragmented, and no solutions were built to enable existing clinics. Pair came out of that need and provides a simple yet comprehensive solution that covers the front, mid, and back-office. Their automation, along with a human-in-the-loop approach provides end-to-end operations of patient outreach, scheduling, e-forms, care gap reports, record requests, referrals, lab coordination, etc., to offload the traditional job functions of the front desk and medical assistants.

“Primary care is systematically and chronically under-resourced. Pair ensures patients receive the very best practices in health care — from annual checkups, follow-ups after hospital discharge, and preventative care screenings,” commented Neil Batlivala, CEO and co-founder of Pair Team. “We not only monitor patient data, but we go further to operationalize it with automation and our care team.”

Revenue-Sharing
Business Model

Pair provides a revenue-sharing model to the share cost of operations with primary care providers. The platform monitors health plan and system data to trigger automated workflows that engage patients to schedule clinically impactful visits, surface care recommendations to clinicians, and manage follow-up care coordination. Their bolt-on model allows them to work as an extension of your care team within existing processes and accelerate quality programs in days, not months. For practices, this drastically improves care quality and visit efficiency. For plans, this aligns day-to-day operations with a total cost of care.

Helping Medicaid Populations Navigate Their Healthcare

Medicaid and Medicare is struggling in an unprecedented way during COVID — many workers are losing access to healthcare through their employer and COVID job loss. During the first week of open enrollment, last month nearly 820,000 people selected plans on HealthCare.gov 2020, according to the Centers for Medicare & Medicaid Services (CMS).  Federal Medicaid outlays increased more rapidly through 2nd half FFY 2020, up 22.5% as compared to prior year at 8.7% growth. So the number of patients coming onto the system is at unprecedented levels. 

Pair helps Medicaid populations navigate their healthcare with follow-ups, preventive cancer screening, and those recommendations on current (and ever-changing) Medicaid requirements. The company starts with existing processes and accelerates quality programs in days, not months.

Recent
Traction/Milestones

Despite COVID and patient’s avoidance of medical offices and care, Pair’s wrap-around operations technology and care team tripled the rate of preventative care visits and are on track to increase clinical revenue by 15% by end of the year through quality incentives alone. To date, Pair manages care for thousands of Medicaid patients in southern California and has closed hundreds of care gaps with their remote care team.

What HCPs think about COVID-19’s impact on cancer

COVID-19’s knock-on effect on cancer patients is of concern by HCPs, with delayed or decreased diagnosis seen as a key worry. CREATION.co’s Lara Meyer explores why HCPs need more support.

The COVID-19 pandemic has been mainstream headline news throughout 2020 and continues to have a profound impact on all our lives. A key concern that has emerged from the crisis is how COVID-19 will affect other areas of healthcare, particularly cancer diagnosis and treatment.

To understand what healthcare professionals (HCPs) felt about this topic, CREATION.co investigated public social media, in collaboration with Sermo’s HCP survey platform, Sermo RealTime, which provides real time access to physician insights.

We looked at conversations that HCPs were having online to provide a full picture of their concerns and needs. By designing fast surveys based on insights from the online conversation we were able to get a powerful depth of insight. For the survey we recruited oncologists from the United States, United Kingdom and Spain.

HCPs concern for decreased cancer diagnosis

During the COVID-19 pandemic, delayed or decreased cancer diagnosis was highlighted by HCPs as a key concern. Prominent industry figures, such as oncologist and ex-director of the WHO Cancer Programme Professor Karol Sikora, shared news articles and utilised their networks to raise awareness of decreased cancer diagnosis.

However, only a fraction of HCPs explained why they experienced a decrease. Knowing the “why” can help to address the specific challenges that hospitals are facing to ensure patients are receiving the care they need.

Using Sermo RealTime, we asked physicians to rank why they believe there has been a decrease in diagnosis at their hospital or practice. We discovered that cancellation of appointments by hospitals was perceived to have caused the most impact. The reason ranked as the next factor, was hospital staff being diverted to COVID-19 efforts. Understanding these reasons could help with resource allocation and impact assessments.

On social media, HCPs chose to encourage their peers to continue supporting their oncology patients during the pandemic. Again, key online influencers, such as Dr Tatiana Prowell – a well-known medical oncologist specialising in breast cancer, led a call to prioritise patients and raise awareness of decreased diagnoses. We have seen many HCPs supporting their peers online throughout the pandemic.

Uncertainty around cancer treatment

A significant part of the HCP conversation online discussed treatment of oncology patients. Physicians shared their concerns about delaying or changing treatment approaches and the impact this would have in the long term. When surveying physicians using Sermo RealTime, 79% of HCPs shared that they had delayed their patients’ treatment, while 52% of HCPs opted to change their patients’ treatment approach either by switching the drug their patient is on, or changing the administration timing or dose.

For the pharmaceutical industry, this knowledge could help teams in their communication plans to support HCPs with updated information or guidelines about treatments.

We regularly see HCPs share treatment guidelines on social media to provide support when there is confusion around new or existing treatment approaches, often creating their own guidelines when none exist.

And in our survey of physicians, 58% of respondents shared that regulatory guidelines have been their go-to source for information and advice for treatment during the COVID-19 pandemic, alongside consulting their peers. However, even HCPs’ go-to source did not always provide as much support as they would have liked, with some HCPs sharing that they are still unsure of the correct treatment for patients during the COVID-19 pandemic or for cancer patients that have COVID-19.

After surveying HCPs about how confident they were about the information and advice they have received about continuing treatment for their COVID-19 positive or negative cancer patients, 70% of physicians shared that they were “somewhat confident but consulted with their peers”, showing how important peer support is during this time.

HCPs look to the future

As COVID-19 continues to affect countries around the world, HCPs are concerned about the short-term and long-term implications the pandemic will have on patient diagnosis and care. Despite having to respond reactively day-to-day, and the focus on the here and now, the future is still on HCPs’ minds.

Dr Stephanie Graff, a breast cancer oncologist, shared her concerns about “what this might mean long term—stage at diagnosis for example”, and how to bring patients safely back to care.

When physicians in our survey were asked what some of the key concerns are for them going forward, they shared the backlog of patient cases that will need manual review and further investigations, switching to less effective or immunosuppressive treatments, and patients’ hesitancy or distress preventing them getting treatment. Others also shared the same concern as Dr Graff, that cancer patients present at a later stage because of backlogs and hesitancy to come to hospitals having a much larger impact on the treatment approach for these patients.

Across both open and closed online networks HCPs are concerned about the future of patient care.

The online HCP conversation continues at a steady rate each day with oncologists, nurses and specialists continuing to share their concerns and needs online with peers. Throughout the year, HCPs continue to seek the answers they are looking for and share resources online.

These concerns all present opportunities for pharmaceutical companies, hospitals, advocacy groups and medical organisations to support HCPs in very specific areas. Listening to the voices of HCPs online, especially as they are more active during this time, can help uncover key areas for engagement and support.

About the author

Lara MeyerAt CREATION.co, Lara supports clients in scoping and delivering projects. Her pharmaceutical experience includes laboratory research, as well as in marketing and strategy and she recently completed an MSc in Global Management from the London School of Economics. Working with CREATION.co she leads a team of insight analysts compiling reports.

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Cancer Risk from Arsenic in Rice and Seaweed

A daily half-cup of cooked rice may carry a hundred times the acceptable cancer risk of arsenic. What about seaweed from the coast of Maine?

“At one point during the reign of King Cotton, farmers in the south central United States controlled boll weevils with arsenic-based pesticides, and residual arsenic still contaminates the soil.” Different plants have different reactions to arsenic exposure. Tomatoes, for example, don’t seem to accumulate much arsenic, but rice plants are really good at sucking it out of the ground—so much so that rice can be used for “arsenic phytoremediation,” meaning you can plant rice on contaminated land as a way to clear arsenic from the soil. Of course, you’re then supposed to throw the rice—and the arsenic—away. But in the South, where 80 percent of U.S. rice is grown, we instead feed it to people.

As you can see at 0:52 in my video Cancer Risk from Arsenic in Rice and Seaweed, national surveys have shown that most arsenic exposure has been measured coming from the meat in our diet, rather than from grains, with most from fish and other seafood. Well, given that seafood is contributing 90 percent of our arsenic exposure from food, why are we even talking about the 4 percent from rice?

The arsenic compounds in seafood are mainly organic—used here as a chemistry term having nothing to do with pesticides. Because of the way our body can deal with organic arsenic compounds, “they have historically been viewed as harmless.” Recently, there have been some questions about that assumption, but there’s no question about the toxicity of inorganic arsenic, which you get more of from rice.

As you can see at 1:43 in my video, rice contains more of the toxic inorganic arsenic than does seafood, with one exception: Hijiki, an edible seaweed, is a hundred times more contaminated than rice, leading some researchers to refer to it as the “so-called edible hijiki seaweed.” Governments have started to agree. In 2001, the Canadian government advised the public not to eat hijiki, followed by the United Kingdom, the European Commission, Australia, and New Zealand. The Hong Kong Centre for Food Safety advised the public not to eat hijiki and banned imports and sales of it. Japan, where there is actually a hijiki industry, just advised moderation.

What about seaweed from the coast of Maine—domestic, commercially harvested seaweed from New England? Thankfully, only one type, a type of kelp, had significant levels of arsenic. But, it would take more than a teaspoon to exceed the provisional daily limit for arsenic, and, at that point, you’d be exceeding the upper daily limit for iodine by about 3,000 percent, which is ten times more than reported in a life-threatening case report attributed to a kelp supplement.

I recommend avoiding hijiki due to its excess arsenic content and avoiding kelp due to its excess iodine content, but all other seaweeds should be fine, as long as you don’t eat them with too much rice.

In the report mentioned earlier where we learned that rice has more of the toxic inorganic arsenic than fish, we can see that there are 88.7 micrograms of inorganic arsenic per kilogram of raw white rice. What does that mean? That’s only 88.7 parts per billion, which is like 88.7 drops of arsenic in an Olympic-size swimming pool of rice. How much cancer risk are we talking about? To put it into context, the “usual level of acceptable risk for carcinogens” is one extra cancer case per million. That’s how we typically regulate cancer-causing substances. If a chemical company wants to release a new chemical, we want them to show that it doesn’t cause more than one in a million excess cancer cases.

The problem with arsenic in rice is that the excess cancer risk associated with eating just about a half cup of cooked rice a day could be closer to one in ten thousand, not one in a million, as you can see at 4:07 in my video. That’s a hundred times the acceptable cancer risk. The FDA has calculated that one serving a day of the most common rice, long grain white, would cause not 1 in a million extra cancer cases, but 136 in a million.

And that’s just the cancer effects of arsenic. What about all the non-cancer effects? The FDA acknowledges that, in addition to cancer, the toxic arsenic found in rice “has been associated with many non-cancer effects, including ischemic heart disease, diabetes, skin lesions, renal [kidney] disease, hypertension, and stroke.” Why, then, did the FDA only calculate the cancer risks of arsenic? “Assessing all the risks associated with inorganic arsenic would take considerable time and resources and would delay taking any needed action to protect public health” from the risks of rice.

“Although physicians can help patients reduce their dietary arsenic exposure, regulatory agencies, food producers, and legislative bodies have the most important roles” in terms of public health-scale changes. “Arsenic content in U.S.-grown rice has been relatively constant throughout the last 30 years,” which is a bad thing.

“Where grain arsenic concentration is elevated due to ongoing contamination, the ideal scenario is to stop the contamination at the source.” Some toxic arsenic in foods is from natural contamination of the land, but soil contamination has also come from the dumping of arsenic-containing pesticides, as well as the use of arsenic-based drugs in poultry production and then the spreading of arsenic-laced chicken manure on the land. Regardless of why south central U.S. rice paddies are so contaminated, we shouldn’t be growing rice in arsenic-contaminated soil.

What does the rice industry have to say for itself? Well, it started a website called ArsenicFacts. Its main argument appears to be that arsenic is everywhere, we’re all exposed to it every day, and it’s in most foods. But shouldn’t we try to cut down on the most concentrated sources? Isn’t that like saying look, diesel exhaust is everywhere, so why not suck on a tailpipe? The industry website quotes a nutrition professor saying, “All foods contain arsenic. So, if you eliminate arsenic from your diet, you will decrease your risk…and you’ll die of starvation.” That’s like Philip Morris saying that the only way to completely avoid secondhand smoke is to never breathe—but then you’ll asphyxiate, so you might as well just start smoking yourself. If you can’t avoid it, you might as well consume the most toxic source you can find?!

That’s the same tack the poultry industry took. Arsenic and chicken? “No need to worry” because there’s a little arsenic everywhere. That’s why it’s okay the industry fed chickens arsenic-based drugs for 70 years. If you can’t beat ’em, join ’em.

How can the rice industry get away with selling a product containing a hundred times the acceptable cancer risk? I cover that and so much more in my other videos on arsenic and rice, which also include concrete recommendations on how to mediate your risk.


Check out:

Pesticides were not the only source of arsenic. Poultry poop, too, if you can believe it! I cover that story in Where Does the Arsenic in Chicken Come From? and Where Does the Arsenic in Rice, Mushrooms, and Wine Come From?.

Chronic low-dose arsenic exposure is associated with more than just cancer. See The Effects of Too Much Arsenic in the Diet.

In health,

Michael Greger, M.D.

PS: If you haven’t yet, you can subscribe to my free videos here and watch my live presentations:

FDA puts Bellicum’s cancer cell therapy trial on hold

The FDA has placed a clinical hold on a phase 1/2 trial of Bellicum’s cancer cell therapy BPX-601, following a patient death.

Houston, Texas-based Bellicum said that the regulator had placed recruitment and dosing on hold in the dose-escalation trial in patients with previously treated metastatic pancreatic cancer or prostate cancer.

Bellicum is hoping to develop a next-generation CAR-T that has the firepower to tackle solid tumours, something that approved therapies from companies such as Novartis and Gilead are unable to do.

The action was due to the death of a pancreatic cancer patient in the trial reported to the agency by the company and the clinical investigator. Bellicum classified the patient death as unrelated to BPX-601 and rimiducid.

Shares in the biotech were sharply down after the announcement, which came only a few weeks after the company cut development staff following a readout from the trial suggested BPX-601 was not capable of shrinking tumours.

The company had continued with the trial to further investigate how the drug was working and Bellicum said it would work with the FDA to resume the trial.

Recruitment on to a separate phase 1/2  clinical trial of BPX-603, described as a dual-switch cell therapy in patients with HER2+ solid tumours will still go ahead in the coming weeks.

BPX-601 is the company’s first potential drug candidate, a CAR-T cell therapy that is designed to enable production of cytokines and enable the drug to override cancer mechanisms that inhibit the immune system.

The company has dubbed the technology CoCAR-T, which activates two receptors – MyD88 stimulates functioning within immune cells, while stimulating CD40 promotes anti-tumour action from T-cells.

CD40 can also re-educate macrophages to destroy tumour stroma – dense thickets of cells that act as a physical barrier between the cancer and the rest of the body that cell therapies struggle to penetrate.

 

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Exelixis takes $20m option Iconic/Zymeworks’ cancer ADC

Exelixis has taken a $20 million option to license in an antibody-drug conjugate cancer (ADC) drug from Iconic, with clinical trials expected to start next year.

The California biotech had reached an agreement with Iconic and Zymeworks giving the option on the drug in May last year.

Probably best known for the cancer drug Cabometyx (cabozantinib), which is marketed by Ipsen outside of the US and Japan, Exelixis already has four small-molecule drugs on the market.

But CEO Michael Morrissey has selected ADCs as an area of research focus, and announced two partnerships in this field with Swiss startup NBE Therapeutics and Catalent Pharma in September.

After taking the option Exelixis now has responsibility for clinical development, marketing and manufacturing of the Tissue Factor (TF) targeting drug known as XB002.

The drug consists of an antibody targeting TF, coupled with a linker and cancer-killing payload developed by Zymeworks.

Exelixis plans to file for clinical trial clearance with the FDA shortly and plans to take it into a phase 1 trial involving solid tumours early next year.

Exelixis gained an exclusive option to license XB002 (then ICON-2) in exchange for an upfront payment to Iconic of $7.5 million and a commitment of preclinical development funding.

Iconic is now also eligible for future development, regulatory and commercialisation milestone payments, as well as royalties on potential sales.

Zymeworks, based in Vancouver, will also get a share of the option fee and could also receive a share of all future revenue and any sales royalties under an agreement licensing the drug to Iconic.

Exelixis said it decided to take the option after preclinical studies showed that the drug binds to Tissue Factor without affecting the blood clotting cascade, which has held back development of other molecules aimed at the target.

Although it is an important part of the blood clotting process in healthy cells, tissue factor is also expressed by tumours.

It contributes to several of the processes that help cancers grow, including thrombosis, metastasis and growth of blood vessels that feed oxygen to the tumours.

 

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The Effects of Too Much Arsenic in the Diet

Even at low-level exposure, arsenic is not just a class I carcinogen, but may also impair our immune function and increase our risk of cardiovascular disease and diabetes.

When people hear about arsenic, they think of it as an acute poison, and, indeed, a tiny amount—a hundred milligrams, about one-tenth the weight of a paperclip—could kill you in an hour. But, there is also chronic arsenic poisoning, where even a dose 10,000 times as small can be harmful if you’re exposed day-after-day for years at a time as I discuss in my video The Effects of Too Much Arsenic in the Diet. Chief among the concerns is cancer.

Arsenic is classified as a class I carcinogen, which is the highest level and includes things known to cause cancer in humans. Other class I carcinogens are asbestos, cigarette smoke, formaldehyde, plutonium, and processed meat (the consumption of bacon, ham, hot dogs, deli meat, and the like). So, arsenic is pretty bad, to say the least, implicated in tens of thousands—or even hundreds of thousands—of cancer cases worldwide every year.

Of course, cancer is our number-two killer. What about heart disease, our leading cause of death? “Long-term exposure to low to moderate arsenic levels was associated with cardiovascular disease incidence and mortality,” meaning heart attacks and strokes.

Arsenic is also considered an immunotoxicant, meaning it’s toxic to our immune system. How do we know that? There’s a virus called varicella, which is what causes chickenpox—the first time we get it. Our immune system is able to stamp it down but not stamp it out. The virus retreats into our nerve cells where it lies in wait for our immune function to dip. And, when it does, the virus re-emerges and causes a disease called shingles. We’ve all been exposed to the virus, but only about one in three of us will get shingles because our immune system is able to keep it at bay. However, the virus can slip its muzzle as we get older or immunosuppressed, for instance, if we’re given arsenic chemotherapy. Shingles is a common side effect, because the arsenic drugs not only kill the cancer but also some of our immune cells, too. That’s at high doses, though. Might even low doses of arsenic, like the kind we’re exposed to in our daily diet, impact our immune function? Researchers tested the levels of arsenic in the urine of thousands of Americans, along with their levels of anti-virus antibodies, and, indeed, they found that the more arsenic the subjects had flowing through their bodies, the lower their defenses.

And, if you’re pregnant, arsenic can pass to your baby, possibly increasing the risk of miscarriage or infant mortality, and “may affect an infant’s immune development and susceptibility to infections early in life.” Indeed, a study out of New Hampshire on infant infections in relation to prenatal arsenic exposure found that the more arsenic the mom was exposed to during pregnancy, the higher the baby’s risk of infection during infancy. However, “it’s unknown whether arsenic-induced epigenetic changes are transgenerational”—that is, whether changes in gene expression can impact the health of not only your own children but your grandchildren as well. Regardless, arsenic exposure isn’t good for mom’s own health, as it is associated with increasing blood pressure.

Hold on. If arsenic suppresses immune system function, then, as a silver lining, would we, for example, have fewer allergies, which is a kind of over-reaction of the immune system? Apparently not. Those with higher arsenic levels tend to have higher rates of food allergies, tend not to sleep as well, and tend not to feel as well. When people were asked how they would rate their health, those reporting “excellent” or “very good” tended to have lower levels of arsenic, compared to those who reported their general health condition as “good,” “fair,” or “poor,” who tended to have higher arsenic levels.

What about diabetes? You can see the results of two dozen population studies on arsenic exposure and confirmed diabetes at 4:07 in my video. Any result above one suggests increased risk for diabetes, and any result below one suggests lower risk. The findings? “Our results support an association between ingested arsenic and DM [diabetes] in humans.” Population studies can’t prove cause and effect, though. “While it would be nice to demonstrate a cause and effect relationship…is it necessary?”

We know arsenic is a carcinogen. We know it causes cancer. What more do we need to take steps to decrease our exposure?

Where is arsenic found in our diet? See my videos Where Does the Arsenic in Chicken Come From?  and Where Does the Arsenic in Rice, Mushrooms, and Wine Come From?.


 Ready for a deep dive into the rice issue? Check out:

In health,

Michael Greger, M.D.

PS: If you haven’t yet, you can subscribe to my free videos here and watch my live presentations:

 

 

 

Merck KGaA signs DNA damage response cancer deal with Artios Pharma

Germany’s Merck KGaA has joined with UK-based Artios Pharma in a potential multi-billion dollar deal to investigate novel DNA damage response targets in cancer.

The principle of DNA damage response is already being exploited by AstraZeneca and other companies with their poly (ADP-ribose) polymerase (PARP) inhibitor drugs.

These target the inherent genetic instability in certain cancer cells, which have switched to a backup mechanism to repair damage to their DNA code.

Turning off this mechanism causes tumour cells to die without affecting healthy tissue –  a concept scientists term “synthetic lethality”.

German Merck said it plans to work with Artios, a DNA damage response (DDR) collaboration involving Cancer Research UK and research partners worldwide, to find anticancer drugs that exploit a similar mechanism.

Artios will receive $30 million in up-front and near-term payments, plus double-digit option fees and up to $860 million in total milestones per target.

It will also receive up to double digit royalty payments on net sales of each product marketed by Merck KGaA.

Darmstadt-based Merck KGaA will contribute its expertise in DDR and will have exclusive worldwide rights to develop and market selected therapeutics discovered under the collaboration.

The partnership will focus on nucleases, which cancer cells depend on for their survival to repair DNA damage.

In certain cancer with mutations in DNA DDR pathways, inhibiting important nucleases can lead to cancer cell death.

The collaboration does not include Artios’ lead drugs, Pol theta and ATR inhibitors, for which Artios will retain rights.

Artios was founded by SV Health Investors in 2016 and has a partnership with Cancer Research UK, plus collaborations with DNA repair researchers worldwide such as the Institute of Cancer Research in London, the Netherlands Cancer Institute and the National Centre for Biomolecular Research at Masaryk University in the Czech Republic.

Backed by blue-chip investors including AbbVie Ventures, Novartis Venture Fund, Pfizer Ventures Artios is based at the Babraham Research Campus in Cambridge, UK, with offices in New York City.

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Virtual Engagement During COVID Pushes Paradigm Shift for Physician Training and Patient Care

Virtual engagement during COVID pushes paradigm shift for physician training and patient care
Shalini Shah, MD is Vice-Chair and Associate Professor, Department of Anesthesiology & Perioperative Care, and Enterprise Director of Pain Services, UC Irvine Health

The dominant presence of COVID-19 has not meant the absence of cancer, ear infections, heart attacks, chronic pain, or other illnesses that need attention and care. Physicians have continued treatment for all types of maladies, and physician training has continued as well. But this treatment and this training look much different these days. Despite the challenges that came with major COVID shutdowns and changing requirements, the healthcare system and patients have been both creative and resilient in finding robust “temporary” solutions to these challenges. It is now looking like some of these COVID-era transitional steps will be preserved and play a lasting role in the future of medical education and telemedicine. What must be sacrificed to reap the benefits of these new protocols?

The rapid adoption of technology and virtual engagement tools has been both impressive and interesting to watch – Zoom meetings between medical association boards of directors, FaceTime calls between isolated patients and their family members at home, telehealth phone appointments with family practice physicians, or virtual medical conferences through Webex – the increasing reliance on these tools has pushed boundaries and exposed both opportunities and challenges with technology use for the future of healthcare.

As COVID-19 has significantly accelerated the feasibility and acceptance of telehealth care by physicians, patients, and payors, we now see healthcare systems navigating in real-time the complex issues with cybersecurity and patient privacy. Due to waivers, everyday technologies can be utilized right now, including FaceTime, Skype, Facebook Messenger video chat, Google Hangouts, and Zoom, but new regulatory guidance may be needed to develop safe, secure, and patient-friendly telehealth applications for the future. Cyber-security, already an important priority in the healthcare information space, is going to become that much more essential as doctor’s offices and clinics implement even more telehealth protocols faster than they ever would have normally planned or budgeted for.

These changes in practice and patient care have also impacted how controlled substances are prescribed. The Drug Enforcement Agency has modified policies to allow for the remote prescribing of controlled substances during the pandemic. Online counseling, informed consent, and follow-up with patients can be done in a virtual setting. Pill counts can be done in a video call and patients can still have their questions answered regarding their pain therapy, although it is likely that after the crisis, prescribing certain controlled substances may return to in-person visits.   It is important that the regulatory climate continues to evolve at the pace needed to address the changing needs and realities of telehealth in the time of COVID.

While we have all become more comfortable on telehealth platforms, there continues to be an important role for in-person visits. Patients may appreciate the convenience of telemedicine; however, they must understand that it can limit a physician’s ability to perform a thorough examination and possibly reduce the chances of a physician detecting an unexpected complication or condition. 

Moving forward, I expect there will be much greater reliance on telehealth strategies even post-COVID, but it will always have to be balanced with old-fashioned office visits.

Residency training has also experienced a profound shift this year. Conventional teaching approaches have either been cut back or have been canceled due to COVID risks, and reduced access to personal protective equipment (PPE) has limited the amount of time spent with patients being cared for during residency and fellowship programs. But we can’t stop training for the next generation of physicians or providing quality Continuing Medical Education (CME) for practicing physicians. E-learning techniques, such as webinars and online skills training, certainly play a role – and these may offer ways to actually enhance cross-departmental or multidisciplinary collaborative educational sessions. E-learning may be more cost-effective and easier to participate in than traveling to conferences or symposia, but the hands-on learning and deep discussions that can occur in breakout sessions or clinical training modules will need to be replaced somehow. And there must be careful vetting of online content in order to avoid a proliferation of commercially biased information, plagiarized materials, or simply false information. As we all adjust to new settings and styles for learning, there must be purposeful strategies to ensure online lectures are still supported with opportunities for learning from direct patient contact and collegial support.

Despite these concerns and challenges, new models for CME activities actually pose a great opportunity for increased access, cost-effectiveness, and practicality for busy clinicians.

Even before the first case of COVID-19 was diagnosed, technological innovation had already begun to change education, healthcare, and even social relationships. The COVID-19 crisis has simply accelerated the drive and interest in these new tools. But while the technological tools and platforms to a large extent existed years before COVID-19, they have never been used as purposefully, as rapidly, or with such intentionality as they are being used now.

I am sure the shift toward technology and virtual engagement in medicine will not go away when we finally get past the COVID-19 crisis. There will likely be lasting changes with the reliance on distance-medicine techniques for both patient care and physician training. But we must keep a close eye on regulatory frameworks that need to be updated, and make extra efforts to build and maintain patient-physician relationships.


About Shalini Shah, MD

Shalini Shah, MD is Vice-Chair and Associate Professor, Department of Anesthesiology & Perioperative Care, and Enterprise Director of Pain Services, UC Irvine Health.  Dr. Shah completed her residency in Anesthesiology from NYP-Cornell University and a combined fellowship in Adult and Pediatric Chronic Pain at Brigham and Women’s Hospital, Beth Israel Deaconess and Children’s Hospital of Boston, Harvard Medical School. 

Genmab axes development of AXL-targeting cancer drug enapotamab vedotin

Genmab has axed development of its pipeline cancer drug enapotamab vedotin after it failed to show enough activity in a proof-of-concept trial.

The drug is an antibody-drug conjugate where a monoclonal antibody is linked to monomethyl auristatin, a cancer-killing “payload”.

It is targeted against AXL, a signalling molecule that is overexpressed in several haematologic and solid malignancies.

Developing enapotamab vedotin formed a major part in the rationale behind the company’s $506 million Nasdaq IPO last year.

Genmab said it will not advance development of the drug after data from expansion cohorts showed it did not meet stringent criteria for proof-of-concept in the early trial.

There was some evidence of clinical activity but this was not “optimised by different dose schedules and/or predictive biomarkers” the company said in a statement.

The company will instead prioritise development of other drugs in its pipeline.

AXL overexpression is thought to drive several cancer processes, including metastasis, tumour angiogenesis, resistance to chemotherapy and targeted agents, and decreased antitumor immune response.

Enapotamab vedotin is fully owned by Genmab and the drug linker technology used for enapotamab vedotin was licensed from Seagen Inc, formerly known as Seattle Genetics.

Jan van de Winkel, CEO of Genmab, said: “We are committed to developing innovative antibody products for patients with cancer, however the data from the enapotamab vedotin expansion cohorts unfortunately does not support moving this product candidate forward.

“This decision will allow us to focus more of our resources and energy on other programs in our robust next-generation antibody therapeutics pipeline.”

AXL is also being targeted by the Norwegian biotech BerGenBio, which has also been looking at using the pathway to fight inflammation seen in COVID-19.

The company’s bemcentinib is under development as a combination and single agent therapy in lung cancer and leukaemia, as well as COVID-19.

It also has an anti-AXL antibody, tilvestamab, which is undergoing phase 1 testing in cancer.

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Why Was Chicken the Primary Source of Arsenic Exposure in Children?

What was the National Chicken Council’s response to public health authorities calling for the industry to stop feeding arsenic-based drugs to poultry?

“Dietary practices influence our exposure to pesticides, toxic heavy metals, persistent organic pollutants, and industrial pollutants….A diet high in fish and other animal products, for example, results in greater exposure to persistent organic compounds and metals than does a plant-based diet because these compounds bioaccumulate up the food chain.” Researchers at UC Davis analyzed the diets of children and adults in California to see just how bad things have gotten.

Cancer benchmark levels were exceeded by all children—100 percent of children—for arsenic, the banned pesticides dieldrin and DDT, metabolite DDE, as well as dioxins, and not just by a little. As you can see at 0:51 in my video Where Does the Arsenic in Chicken Come From?, researchers found more than a hundred times the acceptable daily exposure for arsenic in preschoolers, school-aged children, parents, and older adults, about ten times the acceptable levels for various pesticides, and up to a thousand times the daily dose for dioxins. Where are all these toxins coming from?

The number-one source of dioxins in the diets of Californian preschoolers, kids, parents, and grandparents appears to be dairy for all age groups, followed by meat, and then white potatoes, refined grains, mushrooms, poultry, and fish.

These days, our DDT legacy is also mostly from dairy. Dieldrin was created as a safer alternative to DDT, but it was banned just two years later, in 1974, though it’s still found in our bodies, mostly thanks to dairy, meat, and, evidently, cucumbers.

Chlordane made it into the 1980s before being banned, though we’re still exposed through dairy (and cukes). Lead is — foodwise — also mostly from dairy, and mercury is not surprisingly mostly from tuna and other seafood. But the primary source of arsenic in children? Surprisingly, mostly from chicken. Why?

Let me tell you a tale of arsenic in chicken. Arsenic is “well known as a poison by anyone who reads mysteries or the history of the Borgias, and with its long and colourful history, arsenic is not something that people want in their food.” So, when a biostatistics student went to the USDA in 2000 in search of a project for his master’s degree, he decided to look into it. He found a startling difference: Arsenic levels in chicken were three times higher than in other meats. His veterinary colleagues weren’t at all surprised and explained that four different types of arsenic-containing antibiotic drugs are fed to poultry—and have been fed to them since 1944.

“While arsenic-based drugs had been fed to poultry since the 1940s, recognition of this source of exposure [for humans] only occurred after appropriate statistical analysis of the data”—that is, after this student churned through the data. It was published in 2004 and expanded upon in 2006. The National Chicken Council (NCC) was none too pleased, saying lots of foods are contaminated with arsenic. “By focusing specifically on chicken, IATP [the Institute for Agriculture and Trade Policy] makes it clear that it is producing a publicity-oriented document focused on the objective of forcing [chicken] producers to stop using these safe and effective products”—by which the NCC means these arsenic-containing drugs. In fact, the NCC admits to using them but says we don’t need to worry because chicken producers use organic arsenic, “not the inorganic form made infamous in ‘Arsenic and Old Lace.’” Okay, so we don’t need to worry—until, apparently, we cook it. When chicken is cooked, it appears that some of the arsenic drug in the meat turns into the ”Arsenic and Old Lace” variety. So, the Poison-Free Poultry Act of 2009 was introduced into Congress, flopped, and was followed by the subsequent introduction of the Poison-Free Poultry Act of 2011. Did the second attempt fare any better? No, legislators once again said pish posh to poison-poor poultry. So, in 2013, a coalition of nine organizations got together and sued the FDA, and by December 31, 2015, all arsenic-containing poultry drugs were withdrawn. As of 2016, arsenic is no longer to be fed to chickens. The bad news is that without giving birds the arsenic-containing drug roxarsone, chicken may lose some of its “appealing pink color.”

In the end, the poultry industry got away with exposing the American public to arsenic for 72 years. “It should be noted that the European Union has never approved drugs containing arsenic for animal consumption” in the first place, saying, Hmm, feed our animals arsenic? No thanks, nein danke, no grazie, non, merci.

Europe has also long since banned the “urgent threat to human health” posed by feeding farm animals millions of pounds of human antibiotics. As you can see at 5:30 in my video, feeding chickens en masse literally tons of drugs like tetracyclines and penicillins to fatten them faster is a problem that gets worse every year instead of better and dates back to 1951 when drug companies whipped out the ALL CAPS in advertisements,  promising “PROFITS…several times higher!”, a dangerous practice the poultry industry has gotten away with for 68 years…and counting.


If you don’t eat poultry and are feeling a little cocky, you may want to check out my 12-video series on arsenic in rice before you gloat too much:

Think feeding arsenic to chickens is weird? Check out Illegal Drugs in Chicken Feathers.

And for more on the critical public health threat posed by antibiotic overuse in animal agriculture, see:

In health,

Michael Greger, M.D.

PS: If you haven’t yet, you can subscribe to my free videos here and watch my live presentations:

Bio-Thera Reports MAA Submission to EMA for BAT1706 a Proposed Biosimilar to Avastin

Shots:

  • The company has submitted an MAAA for BAT1706 to EMA. Bio-Thera seeks a commercial license for all approved indications of bevacizumab in the EU Member States, Iceland, Norway, and Liechtenstein
  • The submission of the MAA for BAT1706 marks it as the first ex-China MAA/ BLA submission. The BLA of the biosimilar for metastatic carcinoma of the colon or rectum and NSCLC is under NMPA’s review
  • The company plans to submit a BLA for BAT1706 to the US FDA by the end of 2020. Bevacizumab is a mAb that targets VEGF thus reduces neovascularization, thereby inhibiting tumor growth

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: Businesswire

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Recent Executive Hires: CVS Health New President, Cleveland Clinic/Amwell Joint Venture Leadership, Others

Neela Montgomery, EVP & President at CVS Pharmacy/Retail

CVS Health Corporation names Neela Montgomery Executive Vice President and President of CVS Pharmacy/Retail, effective November 30, 2020. Montgomery will oversee the company’s 10,000 pharmacies across the United States. Montgomery, currently a Board Partner at venture capital firm Greycroft, most recently served as chief executive officer of furniture retailer Crate & Barrel and has nearly 20 years of global retail experience.


The Cleveland Clinic and Amwell joint venture appoint Egbert van Acht as Executive Vice Chairman to the Board of Directors and Frank McGillin as CEO. Formed one year ago as a first-of-its-kind company to provide broad access to comprehensive, high-acuity care via telehealth, the company has made great progress scaling digital care through its MyConsult® offering. With an initial focus on clinical second opinions, the organization also offers health information and diagnosis on more than 2,000 different types of conditions including cancer, cardiac, and neuroscience issues.


Dana Gelb Safran, Sc.D., SVP at WELL Health

Healthcare industry veteran Dana Gelb Safran, Sc.D. has joined Well Health Inc. as Senior Vice President, Value-Based Care, and Population Health. In her new role, Dr. Safran will expand WELL’s uses to improve healthcare quality, outcomes, and affordability through partnerships with payers and Accountable Care Organization (ACO) providers.


Talkdesk®, Inc., the cloud contact center for innovative enterprises appoints Cory Haynes to lead Talkdesk’s strategy for the financial service industry and Greg Miller to lead the strategy for healthcare and life sciences. Haynes and Miller are key members of the Talkdesk industries team led by Andrew Flynn, senior vice president of industries strategy for Talkdesk.


Mark McArdle, SVP Products & Design at Imprivata

Imprivata appoints Mark McArdle to Senior Vice President of Products and Design. Mr. McArdle has more than two decades of experience in software development, Software-as-a-Service (Saas), in Cybersecurity, and advanced products for the enterprise, SMB, and consumer markets.


Jack Stoddard, Executive Chairman at Eden Health

Eden Health names Jack Stoddard as executive chairman of its board of directors. Formerly serving in COO roles for Accolade and Haven, Stoddard brings two decades of healthcare innovation and operating experience to the board position, providing leadership, wisdom, and counsel during a time of monumental growth and adoption for the company. 


Saurav Chatterjee, PhD., CTO at Augmedix

Augmedix names Saurav Chatterjee Chief Technology Officer. Prior to joining Augmedix, he most recently served as Vice President of Engineering at Lumiata, Inc., where he led the engineering team that built a leading AI platform, focusing specifically on transforming, cleaning, enriching, featurizing, and visualizing healthcare data, and on building, deploying and operationalizing machine learning and deep-learning models at scale.


Philip Vecchiolli, Chief Growth & Strategy Officer, Tridiuum

Tridiuum, the nation’s premier provider of digital behavioral health solutions names Philip Vecchiolli has joined the company as Chief Growth and Strategy Officer. Vecchiolli, who brings over 30 years of experience to the new role, has a successful track record of leading business development for large and mid-size healthcare companies.


Janet Dillione, CEO of Connect America

Connect America appoints Janet Dillione as its new chief executive officer (CEO). Prior to joining Connect America, Dillione worked in the healthcare information services industry as CEO of Bernoulli Enterprise, Inc., GM of Nuance Healthcare, and CEO of Siemens Healthcare IT.


Health Catalyst, Inc. announces that current Chief Financial Officer Patrick Nelli has been named President, effective January 1, 2021. Following Nelli’s promotion to the President role, Health Catalyst has named Bryan Hunt, current Senior Vice President of Financial Planning & Analysis, Chief Financial Officer, also effective January 1, 2021.

Two additional promotions, also effective January 1, 2021, include Jason Alger, Senior Vice President of Finance, to Chief Accounting Officer, and Adam Brown, Senior Vice President of Investor Relations, to Senior Vice President of Investor Relations and Financial Planning & Analysis. 


Rick Howard, Chief Product Officer at Apervita

Apervita hires health IT veteran Rick Howard as Chief Product Officer. In his role, Rick will oversee product vision, innovation, design, and delivery of Apervita’s digital platform, which enables digital quality measurement, clinical intelligence, as well as value-based contract monitoring and performance measurement.

Roberto Simon

Conversion Labs, Inc. appoints Roberto Simon to its board of directors and as the chair of its audit committee. Following his appointment, the board now has eight members, with six serving as independent directors. Mr. Simon currently serves as CFO of WEX (NYSE: WEX), a $6+ billion fintech services provider.


Dr. Isaac Rodriguez-Chavez, Ph.D., MHS, MS.

PRA Health Sciences, Inc. appoints senior FDA official Isaac Rodriguez-Chavez, Ph.D., MHS, MS, as Senior Vice President, Scientific and Clinical Affairs. He will lead the company’s Global Center of Excellence for Decentralized Clinical Trial (DCT) Strategy. Dr. Rodriguez-Chavez’s responsibilities will involve the continued growth and development of PRA’s industry-leading decentralized clinical trial strategy, regulatory framework creation, and clinical trial modernization.


Proprio appoints three global thought leaders to its Medical Advisory Board. Dr. Sigurd Berven, Orthopedic Surgeon and Professor at the University of California, San Francisco, Dr. Charles Fisher, Professor and Head of the Combined Neurosurgical & Orthopedic Spine Program at Vancouver General Hospital and the University of British Columbia, and Dr. Ziya Gokaslan, Professor and Chair of the Department of Neurosurgery at Brown University and Neurosurgeon-in-Chief at Rhode Island Hospital and The Miriam Hospital will apply their globally respected surgical and research expertise to the development of the Proprio navigation platform.


Andrew Bindman, MD, EVP & Chief Medical Officer at Kaiser Permanente

Kaiser Permanente names Andrew Bindman, MD Executive Vice President and Chief Medical Officer.  In this role, Dr. Bindman will collaborate with clinical and operational leaders throughout the enterprise to help lead the organization’s efforts to continue improving the high-quality care provided to members and patients throughout Kaiser Permanente. Dr. Bindman will report directly to Kaiser Permanente chairman and CEO Greg A. Adams.

Dr. Michael Blackman, Chief Medical Officer at Greenway

Greenway names Dr. Michael Blackman Chief Medical Officer at Greenway. Dr. Blackman will further support the company’s ambulatory care customers, ensuring providers are equipped with the solutions and services they need to improve patient outcomes and succeed in value-based care.


Suki expands its leadership team with six key hires to support the company’s rapid commercial growth. Tracy Rentz, formerly Vice President of Implementation at Evolent Health, joins Suki as the Vice President of Customer Success and Operations to lead all customer operations, with a particular focus around deploying new Suki customers. Brian Duffy brings over 20 years of sales experience to Suki, joining the team as Director of Sales-East, after having most recently served as Regional Director at Qventus, Inc. Brent Jarkowski will also join Suki’s sales team this November as the Director of Sales-West, bringing over 15 years of experience in strategic relationship management. Brent joins Suki after serving as Senior Client Development Director at Kyyrus. Together, Brian and Brent will head the company’s efforts in building new partnerships across the country. And Josh Margulies, who previously served as the Director of Integrated Brand Marketing for the Jacksonville Jaguars, will serve as Suki’s new Senior Director of Field Marketing.

Novartis set to overcome $14 billion patent cliff say analysts

Novartis’ pipeline is strong enough to overcome a $14 billion patent cliff as blockbuster drugs face generic competition in the coming years, analysts have said.

Following a briefing with management, a team of analysts led by Peter Welford said that the big Swiss pharma will be propped up by its psoriasis and infectious diseases blockbuster Cosentyx for some time.

Although the drug has lost market share to rivals in psoriasis, there is still more to come from Cosentyx thanks to potential new uses in ankylosing spondylitis, psoriatic arthritis and six new indications.

This will be helped by a new 300mg pre-filled syringe and auto-injector have halved administrations, although there is an intravenous option for administration by doctors treating US Medicare patients.

This is supported by the company’s portfolio of other approved medicines and revenues from its Sandoz biosimilars and generics division.

In the short term, the analysts predict “flattish” Q4 sales, although they noted that the company may benefit from cost savings introduced during the COVID-19 pandemic.

Jefferies expects that the company expects sales of $14 billion could be at risk by 2027 from patent expiries of Tasigna, Promacta, Jakavi, Gilenya and Entresto.

But the analysts said that sales growth will continue despite the headwind thanks to “underappreciated” drugs in the late-stage pipeline.

Four key drugs outlined by Jefferies have combined peak potential of $14 billion –  the high lipoprotein cardiovascular disease drug pelacarsen, iscalimab for organ transplant and Sjogren’s syndrome, the rare disease drug iptacopan and the leukaemia drug sabatolimab.

Other important phase 3 drugs that are due to read out are Lu-PSMA in prostate cancer and canakinumab in lung cancer.

The company’s Sandoz division will also chip in with growing sales from its portfolio of biosimilars – cut-price near-copies of established biologic drugs that have been shown to be as safe and effective in rigorous tests and clinical trials.

Uptake of biosimilars in the US has been better than hoped, perhaps aided by hospitals focusing on cost because COVID-19 has curtailed income from surgery.

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New Legal Push Aims to Speed Magic Mushrooms to Dying Patients

Back in March, just as anxiety over COVID-19 began spreading across the U.S., Erinn Baldeschwiler of La Conner, Washington, found herself facing her own private dread.

Just 48 and the mother of two teenagers, Baldeschwiler was diagnosed with stage 4 metastatic breast cancer after discovering a small lump on her chest, no bigger than a pea. Within weeks, it was the size of a golf ball, angry and red. Doctors gave her two years to live.

“It’s heartbreaking,” she said. “Frankly, I was terrified.”

But instead of retreating into her illness, Baldeschwiler is pouring energy into a new effort to help dying patients gain legal access to psilocybin — the mind-altering compound found in so-called magic mushrooms — to ease their psychic pain.

“I have personally struggled with depression, anxiety, anger,” Baldeschwiler said. “This therapy is designed to really dive in and release these negative fears and shadows.”

Dr. Sunil Aggarwal, a Seattle palliative care physician, and Kathryn Tucker, a lawyer who advocates on behalf of terminally ill patients and chairs a psychedelic practice group at Emerge Law Group, are championing a novel strategy that would make psilocybin available using state and federal “right-to-try” laws that allow terminally ill patients access to investigational drugs.

They contend that psilocybin — whether found in psychedelic mushrooms or synthetic copies — meets the criteria for use laid out by more than 40 states and the 2017 Right to Try Act approved by the Trump administration.

“Can you look at the statute and see by its terms that it applies to psilocybin?” Tucker said. “I think the answer is yes.”

Still, the pair admit they’re pushing a legal theory still untested in the courts. “This is untrodden ground,” Aggarwal said.

This month, Aggarwal, who works at the Advanced Integrative Medical Science Institute, known as AIMS, took the first step toward federal authorization of the substance in Washington state and perhaps across the nation. He submitted an application to manufacture psilocybin to the state’s Pharmacy Quality Assurance Commission, which would allow him to grow psilocybin mushrooms from spores at his clinic and administer them for therapeutic use.

Commission members haven’t yet reviewed the application, but Gordon MacCracken, an agency spokesperson, said there “would be a path” for possible license and use — if the application meets the requirements of state regulators and the federal Drug Enforcement Administration.

Currently, psilocybin use is illegal under federal law, classified as a Schedule 1 drug under the U.S. Controlled Substances Act, which applies to chemicals and substances with no accepted medical use and a high potential for abuse, such as heroin and LSD.

Recently, however, several U.S. cities and states have voted to decriminalize possession of small amounts of psilocybin. This month, Oregon became the first state to legalize psilocybin for regulated use in treating intractable mental health problems. The first patients will have access beginning in January 2023.

It’s part of a wider movement to rekindle acceptance of psilocybin, which was among psychedelic drugs vilified — and ultimately banned — after the legendary counterculture excesses of the 1960s and 1970s.

“I think a lot of those demons, those fears, have been metabolized in the 50 years since then,” Aggarwal said. “Not completely, but we’ve moved it along so that it’s safe to try again.”

He points to a growing body of evidence that finds that psilocybin can have significant and lasting effects on psychological distress. The Johns Hopkins Center for Psychedelic and Consciousness Research, launched this year, has published dozens of peer-reviewed studies based on two decades of research. They include studies confirming that psilocybin helped patients grappling with major depressive disorder, thoughts of suicide and the emotional repercussions of a cancer diagnosis.

Psilocybin therapy appears to work by chemically altering brain function in a way that temporarily affects a person’s ego, or sense of self. In essence, it plays on the out-of-body experiences made famous in portrayals of America’s psychedelic ’60s.

By getting out of their heads — and separating from all the fear and emotion surrounding death — people experience “being” as something distinct from their physical forms. That leads to a fundamental shift in perspective, said Dr. Ira Byock, a palliative care specialist and medical officer for the Institute for Human Caring at Providence St. Joseph Health.

“What psychedelics do is foster a frame shift from feeling helpless and hopeless and that life is not worth living to seeing that we are connected to other people and we are connected to a universe that has inherent connection,” he said.

“Along with that shift in perspective, there is very commonly a notable dissolution of the fear of dying, of nonexistence and of loss, and that’s just remarkable.”

The key is to offer the drugs under controlled conditions, in a quiet room supervised by a trained guide, Byock said. “It turned out they are exceedingly safe when used in a carefully screened, carefully guided situation with trained therapists,” he said. “Almost the opposite is true when used in an unprepared, unscreened population.”

Baldeschwiler is one of several AIMS cancer patients eager to undergo psilocybin therapy. Another is Michal Bloom, 64, of Seattle, who was diagnosed in 2017 with stage 3 ovarian cancer. The anxiety of living with the terminal disease is overwhelming, she said.

“It’s as if someone came up to you, put a gun to the back of your head, whispered, ‘I have a gun to your head and I’ll have a gun to your head for the rest of your life. I may pull the trigger, I may not,’” she said. “How do you live like that?”

Research shows that a single six-hour session of psilocybin therapy may be enough to quell that fear, Aggarwal said. “I’m really interested in a right-to-try approach because it’s really what we need for patients right now,” he said.

Under the state and federal laws, to be eligible for “right-to-try” status, a treatment must have completed a phase 1 clinical trial approved by the federal Food and Drug Administration, be part of active clinical trials and in ongoing development or production.

So far, psilocybin ticks all those boxes, Tucker said.

The FDA has granted “breakthrough therapy” status to psilocybin for use in U.S. clinical trials conducted by Compass Pathways, a psychedelic research group in Britain, and by the Usona Institute, a nonprofit medical research group in Wisconsin. More than three dozen trials are recruiting participants or completed, federal records show.

But access to the drug remains a hurdle. Though psychedelic mushrooms grow wild in the Pacific Northwest and underground sources of the drug are available, finding a legal supply is nearly impossible.

Tucker and Aggarwal asked Usona last summer for a supply of the synthetic psilocybin its researchers produce for clinical trials, but so far have received nothing. Penny Patterson, a Usona spokesperson, said there’s been no “definitive resolution” and that conversations are continuing.

The firm’s reluctance may reflect a larger unease with employing right-to-try laws to speed use of psilocybin, said Dr. Anthony Back, a palliative care physician at the University of Washington.

Back supports the use of psilocybin for cancer patients and has even tried the drug to better understand the experience. But he said using psilocybin outside of formal clinical trials might endanger Usona’s ability to get traditional FDA approval. Adverse events may occur that will have to be reported to the FDA, an agency already watching the research closely.

“I can see why they’re hesitant, to be honest,” Back said. “I think right-to-try is an uphill battle.”

Still, Tucker and other advocates say it’s a battle worth fighting. End of Life Washington, a group focused on helping terminally ill patients use the state’s Death With Dignity Act, recently published a policy that supports psilocybin therapy as a form of palliative care. Other treatments for anxiety and depression, such as medication and counseling, may simply not be practical or effective at that point, said Judith Gordon, a psychologist and member of the group’s board of directors.

“When people are dying, they don’t have the time or the energy to do a lot of psychotherapy,” she said.

Baldeschwiler agrees. With perhaps less than two years to live, she wants access to any tool that can ease her pain. Immunotherapy has helped with the physical symptoms, dramatically shrinking the size of the tumor on her chest. Harder to treat has been the gnawing anxiety that she won’t see her 16-year-old daughter, Shea McGinnis, and 13-year-old son, Gibson McGinnis, become adults.

“They are beautiful children, good spirits,” she said. “To know I might not be around for them sucks. It’s really hard.”

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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COTA Lands $34M to Drive Innovation in Oncology Using Real-World Data

COTA Lands $34M to Drive Innovation in Oncology Using Real-World Data

What You Should Know:

– COTA, Inc., a healthcare technology company that uses
real-world data to bring clarity to cancer care, has secured $34M in funding.

– Access to over one million patient data records and additional
funding support enhanced real-world data and analytics services in oncology.


COTA, Inc., a Boston, MA-based healthcare technology company that uses real-world data to bring clarity to cancer care, today announced it has raised $34 million in Series D funding led by Baptist Health South Florida and ONC Capital with participation from EW Healthcare, Horizon BCBS and other existing investors. This also includes a $20M investment from Varian, who negotiated an option to acquire COTA at a later date.

Bringing Clarity to Cancer

COTA was founded in 2011 by a team of doctors, engineers,
and data scientists to create clarity from fragmented and often-inaccessible
real-world data. The company organizes fragmented, often hidden data from the
real world to provide clarity in cancer care. Combining clinical expertise in
cancer with proprietary technology and advanced analytics, COTA’s platform
helps inform decisions and action in oncology. COTA partners with
providers, payers, and life science companies to ensure that everyone touched
by cancer has a clear path to the right care.

COTA offerings include:

Providers: Curate EHR data that can be
used to drive research and standardization in order to improve patient outcomes
while also reducing costs at your institution.

Payers: Make clinical sense of claims data, providing
insight into performance and related outcomes across sites in order to support
value-based payment models.

Life Sciences: Deeplycurated real-world data accelerates drug development informing the decisions and actions that will deliver the best drugs to patients faster and at a lower cost.

Recent Traction/Milestones

The company will use the latest round of funding to expand
its data access by over 300%, which now well exceeds one million oncology
patient records. This growth will support the company’s commitment to
accelerating the use of real-world data to improve patient outcomes and
increase efficiency in oncology drug development. data helps life science
partners answer key research questions, and in 2020 alone, COTA is projected to
double its life science customers, growing from 8 to 16.

“COTA is proud to receive this validation from leading institutions across the oncology ecosystem.” said Michael Doyle, President and CEO of COTA. “The additional capital combined with our increased data access positions COTA for tremendous growth and enables us to drive innovation in oncology using real-world data. Our high-quality data and technology solutions will improve how cancer is treated and provide much needed clarity to patients as they navigate their cancer journey.”

Volaris Group Acquires Clinical Workforce & Workflow Platform medaptus

Volaris Group Acquires Clinical Workforce & Workflow Platform medaptus

What You Should Know:

– Volaris Group acquires medaptus, a clinical workforce, and workflow solutions that empower healthcare delivery entities to achieve their desired patient, clinical and financial outcomes.


Today, Volaris Group has acquired medaptus, a healthcare technology company that removes the administrative burden from hospital and group practice operations to enable higher efficiency throughput.

Removing common and costly workflow barriers from provider
workflows.

medaptus’ clinical workforce and workflow solutions empowers healthcare delivery entities to achieve their desired patient, clinical and financial outcomes. medaptus has applied information technology to solve problems that are common and costly to healthcare organizations that include single-specialty groups, acute care hospitals, hospital medicine teams, ambulatory care settings, and cancer centers. The company’s information technology solutions enable better revenue capture and integrity, hospital medicine workflows that make sense, and computer-assisted coding for infusion services coding processes.


Volaris Group Background

Volaris has a successful track record of acquiring,
strengthening, and growing vertical market software companies. The medaptus
acquisition expands the company’s footprint in the healthcare information
technology space. Financial details of the acquisition were not disclosed.

Volaris acquires, strengthens, and grows vertical market technology companies. As an operating group of Constellation Software Inc., Volaris is all about strengthening businesses within the markets they compete in and enabling them to grow – whether that growth comes through organic measures such as new initiatives and product development, day-to-day business, or through complementary acquisitions.

“We are delighted to welcome medaptus to our team. The company complements our current healthcare portfolio, adding new customers and unique automation capabilities to the mix. medaptus software solutions address a number of important issues in healthcare and the company’s outstanding track record and service quality reputation provide an excellent opportunity for future growth and innovation,” said Michael Melville, Group Leader at Volaris Group.

Lead Pharma signs $308m deal to develop small molecule drugs with Roche

Lead Pharma has signed a potential 260 million euro ($308 million) deal with Roche to develop small molecule drugs for immune diseases.

The deal will revolve around a single undisclosed drug target and will see the Dutch biotech receive 10 million euros up front from Roche.

Lead will lead the selection of a pre-clinical drug candidate, after which Roche will be responsible for further development and global marketing.

Based in Oss-Netherlands, Lead will be eligible to receive research funding and pre-clinical milestone payments; total potential payments including research, development, regulatory and sales milestones may add up to 260 million euros, plus royalties on worldwide sales.

The biotech’s chief scientific officer Arthur Oubrie said: “Our rigorous target selection process, translational screening cascade, and smart medicinal chemistry have been essential to bring this project to this stage. We are keen to collaborate with our colleagues at Roche to bring this novel approach to patients.”

The company has been working with Sanofi since 2015 on a small molecule targeting ROR gamma, a regulator of T-helper 17 immune cells.

It has already received four milestone payments under this first agreement, which targets autoimmune disorders including common diseases such as psoriasis, rheumatoid arthritis and  inflammatory bowel disease.

In March last year Sanofi began a phase 1 clinical trial of the treatment , triggering the most recent payment.

Roche is clearly looking to expand from the cancer beat where it has made most of its money in the last few decades.

Sales of its “big three” cancer drugs Avastin, Herceptin and Rituxan are slipping away because of competition from cheaper biosimilars.

It has had limited success with newer oncology drugs, which have not produced the annual sales of more than $20 billion generated by these drugs at their peak.

Roche last year signed a $792.5 million deal with immune-mediated disease focused Rheos Medicines, based in Cambridge, Massachusetts.

The US biotech got $42.5 million up front, with a further $90 million due in research and pre-clinical development milestones.

The remainder will come from development, regulatory and sales milestones, plus tiered royalties.

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The Antioxidant Power of Açaí vs. Apples

There are so many açaí products on the market now, from frozen pulp in smoothie packs to freeze-dried powder and supplements. How is it eaten traditionally? “In the Brazilian Amazon, the Indian tribes of the forest cut down the tree and eat the palm heart…then urinate on the rest of the tree to attract a species of palm beetle to lay its eggs inside the tree. Several weeks later, they return to harvest 3–4 pounds of beetle grub larvae….” I think I’ll just stick to my smoothie pack.

“Despite being used for a long time as food and beverage” in the Amazon, açaí berries have only been researched scientifically since the beginning of this century. A number of years ago, I reviewed that research in my video Clinical Studies on Açaí Berries, starting with in vitro studies showing that açaí could kill leukemia cells in a petri dish at levels you might expect to find in the bloodstream after eating one or two cups of açaí pulp and could also cut the growth of colon cancer cells in half.

Unfortunately, as I discuss in my video The Antioxidant Effects of Açaí vs. Apples, subsequent published studies have failed to find such benefits for that particular type of colon cancer, a different type of colon cancer, or an estrogen-receptor negative form of breast cancer. An açaí extract did appear to kill off a line of estrogen-receptor positive breast cancer cells, but to achieve that level of açaí nutrients in your breast, you’d have to eat about 400 cups of açaí pulp.

The problem with many of these petri dish studies is that they use concentrations that you could never realistically achieve in your bloodstream. For example, as you can see at 1:48 in my video, açaí berries may exert a neuroprotective effect, blocking the buildup of amyloid fibers implicated in Alzheimer’s—but only at a dose reached by drinking about 2,000 cups at one time. They may also have an anti-allergy effect or decrease bone loss—at a mere 1,000 cups a day.

In my previous video Clinical Studies on Açaí Berries, I also talked about a clinical study in which subjects were asked to drink less than a cup a day of açaí in a smoothie. They appeared to get significant improvements in blood sugar, insulin levels, and cholesterol. Now, there was no control group and it was a small study, but there’d never been a bigger study trying to replicate it until a study published in 2016.

As you can see at 2:37 in my video, researchers gave subjects the same amount of açaí for the same duration as the previous study, but they found no significant improvements in blood sugars, insulin, or cholesterol. Why did this study fail to show the benefits seen in the first study? Well, this study was publicly funded with “no conflicts of interest,” while the first study was funded by an açaí company, which always makes you suspect that perhaps it was somehow designed to get the desired result. And, indeed, the participants in that first study were not just given açaí smoothies, but they were explicitly told to avoid processed meat, “for example bacon and hot dogs.” No wonder their numbers looked better at the end of the month. Now, the new study did find a decrease in markers of oxidative stress in the participants’ bloodstreams, a sign of how rich in antioxidants açaí berries can be.

Those who hock supplements love to talk about how açaí consumption can “triple antioxidant capacity” of your blood. And, if you look at the study they cite, you’ll find that the antioxidant capacity of participants’ blood did actually triple after eating açaí—but the same or even better tripling was achieved after consuming just plain applesauce, which the researchers used as a control that happens to be significantly cheaper than açaí berries or supplements. You can see the graph at 3:42 in my video.

A new study has shown significant improvements in artery function after eating açaí berries, but are they any more effective than other common fruits and vegetables? You can learn more about that in my video The Benefits of Açaí vs. Blueberries for Artery Function.


What’s so great about antioxidants? Check out:

Where else can you get them? See Flashback Friday: Antioxidants in a Pinch and Antioxidant Power of Plants vs. Animal Foods.

What are the nutritional aspects of those grub-kabobs? See Bug Appétit: Barriers to Entomophagy and Good Grub: The Healthiest Meat.

In health,

Michael Greger, M.D.

PS: If you haven’t yet, you can subscribe to my free videos here and watch my live presentations:

Fresh doubts over BMS’ merger payout as FDA delays key drug review

Holders of a risky “bet” on three Bristol-Myers Squibb drugs are looking increasingly unlikely to get their pay-out after the company said COVID-19 travel restrictions are delaying a key regulatory review.

Shareholders in Celgene received a contingent value right (CVR) at the time of the company’s $74 billion merger with BMS last year, which pay out $9 each if the FDA approves three medicines before certain deadlines.

There were already concerns at the beginning of the month when BMS said in its Q3 results that the FDA had not yet inspected a manufacturing facility for the B-cell lymphoma CAR-T therapy lisocabtagene maraleucel (liso-cel), one of the three drugs.

BMS has confirmed the worst, saying in a statement that the FDA has delayed a decision on liso-cel until it can visit the facility – something that is proving difficult because of COVID-19 travel restrictions. Liso-cel has to be approved by the end of the year for the CVR to pay out.

The FDA was due to make a regulatory decision on liso-cel next week, and with the deadline laid out in the CVR looming there are now serious concerns about whether holders of the publicly traded instrument will receive their cash.

The announcement sent the value of the CVR down sharply in pre-market trading as there are also concerns about whether the third drug in the “bet” will be approved on time as well.

Multiple myeloma CAR-T idecabtagene vicleucel (ide-cel) – has to be approved by 31 March next year, just four days after the FDA’s action date.

The first of the three CVR medicines, Celgene’s multiple sclerosis drug Zeposia (ozanimod) was approved in March.

While CVR holders are feeling the pressure, there are no such worries for BMS, which has seen its revenues rocket thanks to the merger.

BMS revenues rose 75% in Q3 to $10.5 billion thanks to the addition of Celgene, but were up 6% on a pro forma basis

BMS said that it is “committed to working with the FDA to progress both applications to achieve the remaining regulatory milestones required by the CVR.”

But if the CVR does not pay out, it won’t be the first time that investors have been burnt by such a deal.

Last year Sanofi settled a long-running dispute with shareholders in the biotech Genzyme, who claimed the French pharma held back development of a multiple sclerosis drug to avoid CVR payments after a takeover in 2011.

Sanofi said it had agreed to pay Genzyme investors $315 million to settle the lawsuit.

As part of Sanofi’s $20 billion takeover of Genzyme, the French drugmaker promised shareholders in the US biotech payouts under a CVR that was due when MS drug Lemtrada (alemtuzumab) achieved certain regulatory and sales milestones.

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German biotech CatalYm raises €50 million for GDF-15 inhibitor immunotherapy

CatalYm has closed a €50 million ($59m) series B financing round to fund clinical studies of its immunotherapy targeting Growth Differentiation Factor 15 (GDF-15).

The round was led by Vesalius Biocapital III, with participation from Novartis Venture Fund (NVF), Wachstumsfonds Bayern, coparion and founding investors Forbion and BioGeneration Ventures.

Founded in 2016 as a spin-out from Wuerzburg University, CatalYm’s lead molecule CTL-002 is designed to neutralise the tumour-produced protein GDF-15. High concentrations of the GDF-15 in serum and tumour-micro-environment help cancers to evade the immune system and are associated with resistance to current therapies.

The therapy originated from research by company founder Professor Wischhusen, looking at similarities between how a tumour protects itself from attacks by the immune system and how foetuses grow during pregnancy with protection from the immune system of the mother.

“In both cases, the tissue is growing very rapidly and aggressively and there is a need for vascularisation, nutrients and to escape the immune system. In pregnancy, of course this is what is needed and allows a baby to grow. But if a tumour is doing the same then it is going to kill a patient,” CatalYm CEO Dr Manfred Ruediger told pharmaphorum. “A tumour often hijacks these mechanisms which benefit the foetus and that is how the whole story started.”

CTL-002 addresses three of the tumour’s immune suppressive mechanisms all involving the inhibitory effect of GDF-15 on the immunostimulatory LFA-1/ICAM-1 interaction. By neutralising GDF-15, CTL-002 is expected to enhance infiltration of immune cells into the tumour, improve priming of T-cells by dendritic cells and improve the tumour killing by T-cells and NK-cells.

The company is expecting to be at clinical stage by the end of the year. Proceeds from the series B raise will be used for a Phase I escalation trial. CatalYm will also test the compound in combination with approved checkpoint blockers. If shown to work with approved immuno-oncology drugs, it could benefit patients that relapse or are in refractory from current therapies.

According to Ruedinger, investors believed the clinical program had more potential compared to others in immunotherapy. “We are not another company activating immune cells or improving antigen exposure,” he said. “We are the only one which is working on the step where immune cells must leave the vessels which nourish the tumour and enter the tumour tissue properly. It’s fascinating for all of us and we are looking forward to the next stage.”

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Merck & Co/Eisai eye kidney cancer use for immunotherapy combination

Merck & Co and Eisai are to file results from a phase 3 trial testing a combination of the former’s immunotherapy Keytruda, combined with the latter’s cancer drug Lenvima in untreated patients.

Keytruda (pembrolizumab) and Lenvima (lenvatinib) outperformed standard care – Pfizer’s Sutent (sunitinib) – in untreated patients with advanced renal cell carcinoma when measured against progression-free survival (PFS) and secondary goals of overall survival (OS) and overall response rate (ORR).

The companies said the results in the intention to treat population would be shared with regulators across the world.

Merck & Co, known as MSD outside North America, gave no further details about the results but said that the improvements were “statistically significant and clinically meaningful” in the group that included across all risk group categories – favourable, intermediate and poor.

Results came from the 1,050 patient KEYNOTE-581/CLEAR trial, also known as Study 307, testing Lenvima in combination with Keytruda or in combination with everolimus, with patients taking Pfizer’s Sutent in the control group.

Patients were randomly assigned to three groups, either receiving Lenvima (18mg orally once daily) in combination with everolimus (5mg orally daily), Lenvima (20mg orally once daily) plus Keytuda (200mg intravenously every three weeks), or Sutent daily once daily for four weeks on treatment followed by two weeks off treatment.

The primary endpoint is PFS by independent review per RECIST v1.1 criteria.

Further details will be revealed at an upcoming medical meeting.

Keytruda was approved in combination with Pfizer’s Inlyta (axitinib) in first line kidney cancer last year, which is competing against the combination of BMS’ rival PD-1 inhibitor Opdivo (nivolumab) and CTLA4 inhibitor Yervoy (ipilimumab).

Merck KGaA/Pfizer’s Bavencio (avelumab), was approved for first-line RCC in combination with Inlyta in May last year.

US-based Merck and Eisai are continuing to study the Keytruda plus Lenvima combination through the LEAP (LEnvatinib And Pembrolizumab) clinical program across 19 trials in 13 different tumor types (endometrial carcinoma, hepatocellular carcinoma, melanoma, non-small cell lung cancer, RCC, squamous cell carcinoma of the head and neck, urothelial cancer, biliary tract cancer, colorectal cancer, gastric cancer, glioblastoma, ovarian cancer and triple-negative breast cancer).

 

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M&A: RxVantage Acquires onPoint Oncology to Expand Offering to Oncology Practices

M&A: RxVantage Acquires onPoint Oncology to Expand Offering to Oncology Practices

What You Should Know:

– RxVantage has acquired onPoint Oncology to provide cancer care teams with on-demand access to educational resources, reimbursement data, and analytics.

– The acquisition of onPoint Oncology builds on
RxVantage’s rapidly expanding digital offerings for providers. In April,
RxVantage launched Virtual Meetings to help providers reestablish access to
life science experts amidst the disruptions caused by COVID-19.


RxVantage, the
leading digital platform connecting healthcare providers to educational
resources and experts from life science companies, today announced the acquisition
of onPoint Oncology,
the leader in oncology reimbursement data and analytics.

The partnership ensures that care teams will have access to
onPoint’s unique revenue cycle
data and reimbursement insights as well as one-click access to educational
resources and expertise from any life science company, all through the free RxVantage digital platform.

The acquisition of onPoint Oncology builds on RxVantage’s
rapidly expanding digital offerings for providers. In April, RxVantage launched
Virtual Meetings to help providers reestablish access to life science experts
amidst the disruptions caused by COVID-19.

onPoint will operate as a wholly-owned subsidiary of
RxVantage. As part of the acquisition, industry veterans Tracy Lewis and Bobbi
Buell will join RxVantage leadership team. Financial details of the acquisition
were not disclosed.

RxVantage Background

Founded in 2007, RxVantage’s mission is to ensure that every
provider has the most relevant information and data on medications and medical
technologies, in order to deliver the best care to every patient. More than
6,000 medical practices across the US utilize RxVantage to connect and engage
with over 50,000 experts from life science companies.

NICE backs chemo-free CLL combination from AbbVie and Roche

Previously treated patients with chronic lymphocytic leukaemia (CLL) in England will get a chemotherapy-free treatment option after NICE recommended NHS funding for a combination of AbbVie’s Venclyxto and Roche’s Gazyva.

The decision by NICE allows for the 12-month fixed duration treatment option based on data from the phase 3 CLL14 trial.

This showed the combination of Venclyxto (venetoclax) and Gazyva (obinutuzumab) had superior progression-free survival and sustained that benefit after stopping treatment compared with those receiving a commonly used chemoimmunotherapy regimen of Gazyva and chlorambucil chemo.

NICE recommended the combination in patients with del(17p)/TP53 mutation and those without del(17p)/TP53 mutation for whom fludarabine, cyclophosphamide and rituximab (FCR) or bendamustine and rituximab (BR) are unsuitable.

The cost-effectiveness body also recommended the combination for use within the Cancer Drugs Fund (CDF) for patients without del(17p)/TP53 mutation and for whom FCR or BR are suitable, subject to a managed access agreement.

The combination therapy will be available to NHS patients in England immediately.

CLL is the most common type of chronic blood cancer, with around 10 new patients diagnosed every day.

Unlike some cancers, CLL has a highly variable clinical course so patients are usually left to ‘watch and wait’, after which some patients will be offered appropriate treatment.

However, despite novel therapeutic advancements in CLL, the disease remains incurable and patients will often relapse following treatment.

Professor Peter Hillmen, consultant in clinical haematology at Leeds Teaching Hospitals and honorary professor of haematology at University of Leeds, said that the treatment can produce a “deep response.”

“Ultimately, this has the potential to improve patients’ quality of life and reduce the significant burden of therapy,” he added.

The European Commission approved the combination therapy for the treatment of for adult patients with previously untreated chronic lymphocytic leukaemia in March 2020.

Venetoclax is being developed by AbbVie and Roche. It is jointly marketed by AbbVie and Genentech, a member of the Roche Group, in the US and by AbbVie outside of the US.

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Can Soy Prevent and Treat Prostate Cancer?

As I discuss in my video The Role of Soy Foods in Prostate Cancer Prevention and Treatment, a compilation of 13 observational studies on soy food consumption and the risk of prostate cancer found that soy foods appear to be “protective.” What are observational studies? As opposed to interventional studies, in observational studies, researchers observe what people are eating but don’t intervene and try to change their diets. In these studies, they observed that men who ate more soy foods had lower rates of prostate cancer, but the problem with observational studies is that there could be confounding factors. For example, “people who choose to eat soy also make other lifestyle decisions that lower the risk of cancer (e.g., lower fat intake, higher vegetable and fruit intake, more frequent exercise),” maybe that is why they have less cancer. Most of the studies tried to control for these other lifestyle factors, but you can’t control for everything. What’s more, most of the studies were done in Asia, so maybe tofu consumption is just a sign of eating a more traditional diet. Is it possible that the reason non-tofu consumers got more cancer is that they had abandoned their traditional diet? If only we could look at a Western population that ate a lot of soy. We can: the Seventh-Day Adventists.

In the 1970s, more than 12,000 Adventist men were asked about their use of soy milk and then were followed for up to 16 years to see who got cancer and who did not. So, what did they find? Frequent consumption of soy milk was associated with a whopping 70 percent reduction of the risk of prostate cancer, as you can see at 1:33 in my video. Similarly, in a multiethnic study that involved a number of groups, soy intake appeared protective in Latinos, too.

Prostate cells carry beta type estrogen receptors, which appear to act as a tumor suppressor, a kind of “gatekeeper…inhibiting invasion, proliferation and…preventing” the prostate cells from turning cancerous. And, those are the receptors targeted by the phytoestrogens in soy, like genistein, which inhibits prostate cancer cell invasion and spread in a petri dish at the kind of levels one might get consuming soy foods. The prevention of metastases is critical, as death from prostate cancer isn’t caused by the original tumor, but its spread throughout the body, which explains why it “is recommended that men with prostate cancer consume soy foods, such as soybeans, tofu, miso and tempeh.”

Wait a moment. Dean Ornish and his colleagues got amazing results, apparently reversing the progression of prostate cancer with a plant-based diet and lifestyle program. Was it because of the soy? Their study didn’t just include a vegan diet, but a vegan diet supplemented with a daily serving of tofu and a soy protein isolate powder. There have been studies showing that men given soy protein powders develop less prostate cancer than the control group, but what was the control group getting? Milk protein powder. Those randomized to the milk group got six times more prostate cancer than the soy group, but was that due to the beneficial effects of soy or the deleterious effects of the dairy? Dairy products are not just associated with getting prostate cancer, but also with dying from prostate cancer. Men diagnosed with prostate cancer who then ate more dairy tended to die sooner, and “both low-fat and high-fat dairy consumption were positively associated with an increased risk of fatal outcome.”

The best study we have on soy protein powder supplementation for prostate cancer patients found no significant benefit, and neither did a series of soy phytoestrogen dietary supplements. But, perhaps that’s because they used isolated soy components rather than a whole soy food. “Taking the whole-food approach may be more efficacious,” but it can be hard to do controlled studies with whole foods: You can make fake pills, but how do you give people placebo tofu?

A group of Australian researchers creatively came up with a specially manufactured bread containing soy grits to compare to a placebo regular bread and gave slices to men diagnosed with prostate cancer awaiting surgery. As you can see at 4:31 in my video, they saw a remarkable difference in just about three weeks time. It was the first study to show that a diet incorporating a whole soy food could favorably affect prostate cancer markers, but you can’t just go out and buy soy grit bread. Another study was a little more practical. Twenty men with prostate cancer who had been treated with radiation or surgery but seemed to be relapsing were asked to drink three cups of regular soy milk a day. The PSA levels in each of the 20 patients were all rising before they started the soy milk, suggesting they had relapsing or metastatic cancer growing inside of them. However, during a year drinking soy milk, 6 out of the 20 subjects got better, 2 got worse, and the remaining 12 remained unchanged, as you can see from 5:02 in my video. So, they concluded that soy food may help in a subset of patients.

Based on all these studies, the results Ornish and his colleagues got were probably due to more than just the soy. Similarly, the low prostate cancer rates in Asia are probably because of more than just the soy, since the lowest rates are also found in parts of Africa, where I don’t think they’re eating a lot of tofu. Indeed, in the multiethnic study, other types of beans besides soy also appeared protective for Latinos and all the groups put together, when looking at the most aggressive forms of prostate cancer. So, the protection associated with plant-based diets may be due to eating a variety of healthy foods. 


That soy milk stat from the Adventist study is astounding. What about fermented soy foods, though? That was the subject of Fermented or Unfermented Soy Foods for Prostate Cancer Prevention?.

Reversing the progression of cancer? See How Not to Die from Cancer.

Given the power of diet, it’s amazing to me how difficult Changing a Man’s Diet After a Prostate Cancer Diagnosis can be. It’s not all or nothing, though. Check out Prostate Cancer Survival: The A/V Ratio.

For soy and breast cancer survival, see Is Soy Healthy for Breast Cancer Survivors?.

In health,

Michael Greger, M.D.

PS: If you haven’t yet, you can subscribe to my free videos here and watch my live presentations:

New cancer drugs saved 1.3 million lives

That is the finding from a recent paper by myself and co-authors Joanna MacEwan, Syvart Dennen, Rebecca Kee, Farzad Ali, and Katharine Batt. An excerpt from the paper is below:

Between 2000 and 2016, deaths per 100,000 population across the 15 most common tumor types declined by 24%. Additionally, 10.2 new indications were approved per year across the 15 most common tumor types. Cancer drug approvals were associated with statistically significant deaths averted in 2016 for colorectal cancer (4,991, p = 0.004), lung cancer (33,825, p < 0.001), breast cancer (11,502, p < 0.001), non-Hodgkin’s lymphoma (6,636, p < 0.001), leukemia (4,011, p < 0.001), melanoma (1,714, p < 0.001), gastric cancer (758, p = 0.019), and renal cancer (739, p < 0.001). Between 2000 and 2016, new cancer treatments were correlated with 1,291,769 (p < 0.001) total deaths prevented across the 15 most common tumor types.

Source: MacEwan et al. (2020) courtesy of Journal of Medical Economics.

Do read the whole article here.

Johnson & Johnson Innovation Launches 3 Collaborations to Advance Healthcare in China

Johnson & Johnson Innovation Launches 3 Collaborations to Advance Healthcare in China
Front row (left to right): Jian Chen, Vice President, Xian Janssen Pharmaceuticals; Dan Wang, Head, Johnson & Johnson Innovation, Asia Pacific; Sharona Tao, Leader, Communications & Public Affairs, Johnson & Johnson China; Jennifer Yang, Head, Lung Cancer Initiative China, Johnson & Johnson Back row (left to right): Alex Zhavoronkov, Founder & CEO, Insilico Medicine; Li Peng, Assistant General Manager, Taikang Online Insurance; Gary Ge, Founder, Diannei

What You Should Know:

– Johnson & Johnson Innovation announces three strategic
collaborations with a focus on advancing healthcare solutions in China.

– The three strategic collaborations are focused on leveraging advances in science and technology to address areas of high unmet medical need across several areas, including discovery science, lung cancer, and medical devices


Johnson & Johnson Innovation, a division of Johnson & Johnson (China) Investment Limited, today announced three new collaborations with strategic partners in China. These latest collaborations, facilitated by the Johnson & Johnson Asia Pacific Innovation Center, showcase its broad innovation efforts and focus on leveraging advances in science and technology to address areas of high unmet medical need across several areas, including discovery science, lung cancer, and medical devices.

The collaborations are as follows:

1. Leveraging AI in drug discovery – Janssen Pharmaceutica NV, one of the
Janssen Pharmaceutical Companies of Johnson & Johnson, has established a
multi-target drug discovery collaboration with Insilico Medicine Hong Kong
Ltd., a Johnson & Johnson Innovation – JLABS @ Shanghai resident
company specializing in AI-based drug
discovery.

The agreement will leverage Insilico Medicine’s AI-based platform to design small-molecule hits with the defined properties for several targets nominated by Janssen. The collaboration aims to generate novel and fully patentable chemical scaffolds for difficult targets using AI-based drug designing, potentially leading to significant reductions in time and cost in identifying biologically active hits against selected targets.

2. Developing AI solutions for lung cancer detection
– The Lung Cancer Initiative at Johnson & Johnson in China,
through its affiliate Johnson & Johnson (China) Investment Limited, has entered
into a research collaboration with Diannei (Shanghai) Biotechnology Co. Ltd., a
Chinese company specializing in AI solutions for lung cancer management. The
agreement will see both parties work together to develop computer vision AI for
lung cancer diagnosis. Diannei’s expertise is in developing AI solutions with
deep learning for medical image analysis.

3. Innovative healthcare solutions for sports injury
– Johnson & Johnson Medical (Shanghai) Limited (JJMS) announced an
agreement with Taikang Online Insurance Co. Ltd. (Tk.cn), a Chinese online
healthcare insurance company, to develop an innovative sports injury-related
insurance package. JJMS will support Tk.cn by offering its industrial insights,
while Tk.cn designs reimbursement coverage to sports enthusiasts which aim to
enable timely diagnosis and appropriate surgical treatment for patients.

Why It Matters

“Johnson & Johnson has deep roots in China for the past 35 years to address the growing needs of patients and consumers. We are delighted to mark the third annual CIIE, a significant platform that supports the expansion, innovation and internationalization of the Chinese business environment, by announcing these new collaboration agreements,” said Will Song, Global Senior Vice President, China Chairman, Johnson & Johnson*. “These agreements span a diverse range of focus areas and represent a valuable opportunity to advance human health for the country by connecting global and local innovators with the expertise of the Johnson & Johnson Family of Companies to help transform great ideas into breakthrough solutions.”

After two decades, NICE begins consultation on drug assessment methods

The UK’s drug cost-effectiveness body NICE has launched a public consultation, presenting the case for change about how it assesses medicines, medical devices and diagnostics.

NICE has been assessing medicines for 21 years using the Quality Adjusted Life Year (QALY) – the cost to ‘buy’ a patient a year of quality life – as its main methodology.

Big pharma was never going to be happy about the existence of a body like NICE, which is designed to drive down prices paid by the taxpayer-funded NHS, by far and away the largest payer in the UK.

While industry has begrudgingly found ways to work with NICE to get drugs to the UK market, there have been numerous occasions where manufacturers have felt short-changed by the process and in some cases seen drugs failing to get funding on technicalities.

It’s still true that most drugs are eventually funded after a NICE assessment.

But the consensus is that despite tweaks to the system over the years, reform is needed to keep apace with developments in fields such as cancer.

NICE uses the Cancer Drugs Fund to provide interim reimbursement for cancer drugs that require more survival data and allows more flexibility for drugs used at the end of life.

And the cost-effectiveness threshold of £30,000 per QALY has not moved since NICE began, meaning that manufacturers’ wiggle-room on pricing has been constantly squeezed by inflation.

NICE’s consultation will ask whether additional factors should be included in decision-making, such as the severity of a condition and how health technologies can reduce health inequalities.

It is also asking whether there should be more flexibility in rare diseases, where generating evidence is difficult.

NICE wants feedback on how it assesses highly innovative technology, or those with potentially large benefits where risks could be managed.

The consultation will cover the role of evidence gathered outside clinical trials, such as real-world evidence and how NICE could refine its approach to measuring health-related quality of life in different circumstances.

NICE’s consultation follows an internal review of its number-crunching following commitments made in the voluntary pricing scheme that the government agreed with industry last year.

Steve Bates, chief executive of the Bioindustry Association said: “The proposed changes to NICE’s methods published today send an important signal to the innovative biotech sector that the UK is serious about ensuring access to new medicines.

“We are very encouraged by the focus on removing significant barriers to access, which puts the UK on a new footing, setting the benchmark for health technology appraisals – particularly around modifiers, uncertainty and discounting. It will help ensure both that industry can continue to deliver innovative medicines and that patients can access them.”

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Merck & Co buys cancer biotech VelosBio for $2.75bn

Merck & Co has agreed to buy California biotech VelosBio and its experimental cancer drug for $2.75 billion in cash.

Known as MSD outside North America, the big pharma already has a firm foothold in cancer thanks to its immunotherapy Keytruda (pembrolizumab), which has been on the market for several years and has proven to be effective across a wide range of oncology indications.

But cancer is a highly competitive field and like rivals such as Bristol-Myers Squibb and Roche, Merck & Co is always looking for relatively small acquisitions that could bring in new technology and raise the bar in terms of safety and efficacy.

Based in San Diego, VelosBio is a privately held biotech specialising in a new class of drug that target receptor tyrosine kinase-like orphan receptor 1 (ROR1).

Its lead candidate in clinical development is VLS-101, an antibody-drug conjugate (ADC) targeting ROR1 that is being tested in a phase 1 and a phase 2 clinical trial for patients with blood cancer and solid tumours, respectively.

A phase 2 trial of VLS-101 in solid tumours began last month, including patients with hard to treat triple-negative breast cancer, hormone receptor-positive and/or HER2-positive breast cancer and non-small cell lung cancer (NSCLC).

VelosBio is also due to present detailed results from a phase 1 trial showing a complete response in seven out of a cohort 15 patients with mantle cell lymphoma and four out of five patients with diffuse large B-cell lymphoma.

Patients in that trial had been heavily pretreated and had failed to respond to other anticancer drugs.

The biotech also has a preclinical pipeline of next-generation ADCs and bispecific antibodies targeting ROR1, which could be used in tandem with VLS-101.

The transaction is expected to close at the end of 2020.

In separate announcements Merck said that Lynparza (olaparib), which it develops in partnership with AstraZeneca, had been approved in two new indications in Europe

The new label extensions cover BRCA1/2-mutated metastatic castration-resistant prostate cancer and first-line maintenance treatment for HRD-positive advanced ovarian cancer.

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AstraZeneca and MSD’s Lynparza (olaparib) Receive EU’s Approval as 1L Maintenance Treatment for HRD-Positive Advanced Ovarian Cancer

Shots:

  • The approval is based on a biomarker subgroup analysis of P-III PAOLA-1 study assessing Lynparza + bevacizumab vs bevacizumab alone as 1L maintenance treatment in patients with newly diagnosed advanced FIGO Stage III-IV high-grade serous/ endometrioid ovarian, fallopian tube, peritoneal cancer who had CR/PR to 1L treatment with Pt. based CT and bevacizumab
  • Results: reduction in risk of disease progression or death by 67%, PFS (37.2mos. vs 17.7mos.); PFS2 (50.3mos. vs 35.3mos.)
  • Following the approval, AZ will receive $25M as a regulatory milestone from MSD. The approval follows the CHMP’s positive opinion granted in Sept’2020

Click here to­ read the full press release/ article | Ref: AstraZeneca | Image: Pharmaceutical Technology

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Fermented or Unfermented Soy?

As you can see at the start of my video Fermented or Unfermented Soy Foods for Prostate Cancer Prevention?, there is an enormous variation in the rates of prostate cancer around the globe, with among the highest rates in the United States and lowest rates in Asia—though that may be changing. The largest increase in prostate cancer rates in the world in recent decades has been in South Korea, for example: a 13-fold increase in prostate cancer deaths nationwide. Researchers suggested the increase in animal foods may have played a role, since that was the biggest change in their diet over that period, with nearly an 850 percent increase.

This is consistent with what we know in general about foods and the prevention and management of prostate cancer. Tomatoes, cruciferous vegetables like broccoli, and soy foods appear to decrease risk, there’s no clear benefit from fish, but there is an increased risk associated with meat and dairy, as you can see at 0:52 in my video. This may be because a diet based around whole plant foods “may effectively reduce inflammation in the body.”

There is also a genetic factor. If you have a first-degree relative with prostate cancer, you may be at three-fold higher risk, but non-genetic factors may increase your risk 300-fold. How do we know the low rates in Asia aren’t genetic? Because when Asians move to the United States, their rates shoot up, “and by the second generation, the incidence rate [is] already approaching that of average Americans.” This may be because of more Burger Kings and Dairy Queens, but could also be because of eating fewer protective foods, such as soy.

A systematic review of all soy and prostate cancer population studies to date confirmed that soy foods are associated with lower the risk, but that’s a relatively broad category. There are all sorts of soy foods. There are fermented soy foods, like miso and tempeh, and unfermented ones, like tofu and soy milk. Which are more protective? Researchers sifted through the studies, and it turns out that only the unfermented soy seemed to help. Tofu and soy milk consumption was associated with about a 30 percent reduction in risk, whereas there didn’t appear to be any protection linked to fermented soy foods.


What about other healthy plant foods, like broccoli and turmeric? See what they can do in Best Supplements for Prostate Cancer.

Dean Ornish and his colleagues got amazing results, apparently reversing the progression of prostate cancer with a plant-based diet and lifestyle program. Do you think it could be because of the soy? It wasn’t just a vegan diet, but a vegan diet supplemented with a daily serving of tofu and a soy protein isolate powder. Find out in The Role of Soy Foods in Prostate Cancer Prevention and Treatment.

More on the number-one cancer among men:

What about soy and breast cancer? I’m glad you asked!

Who Shouldn’t Eat Soy? Watch the video to find out!

In health, 

Michael Greger, M.D.

PS: If you haven’t yet, you can subscribe to my free videos here and watch my live presentations:

Be in the room: Turning patient engagement to patient centricity

After three brushes with cancer, Robert Weker understands the patient journey more than many – and he is determined to put that experience to good use.

The avid blogger and passionate advocate retired from his R&D role four years ago to focus on his own health, and now works full time on making sure the patient voice is “in the room” when pharma companies make decisions.

Winding road

“My journey is a bit complicated, because I am a three-time cancer survivor,” said Robert, 60, who lives just outside of Philadelphia in the United States.

“First, it was testicular cancer, back in 1991, then I was diagnosed with liposarcoma in 2010, and pancreatic cancer in 2014.”

His first two cancers were discovered early, and, while he did experience treatment side effects, things were “manageable”, he said.

“My broad ambition is to get medicines and medical solutions that are more accessible, more affordable, and available in a more timely, more patient friendly way.”

“I don’t want to minimise cancer in any way, shape or form, but the testicular cancer was caught early, and the treatment success rate was well over 90%. It was more of an inconvenience. It was like entering a tunnel, but you could already see the light at the end.

“The liposarcoma was a little but different, but it was still caught pretty early and there was a high survival rate. Neither of the cancers significantly disrupted work.”

The pancreatic cancer, however, was a “completely different ball game”.

“At that time, the five-year survival rate was in the order of 7%. So, when I entered that tunnel, it was pretty dark.”

Robert decided to enrol on a clinical trial of chemotherapy plus high dose vitamin D at the University of Pennsylvania. Afterwards, he had to fight for the proton beam radiation therapy his doctor recommended as his insurance company considered it to be experimental.

“I was told my policy didn’t cover it. Even though my entire medical team was saying ‘we can’t do normal radiation because it’s too much exposure and his system as a whole won’t be able to handle it’.

“I am not a passive patient, so I kept calling and calling and finally they said there was a review panel,” said Robert, adding that he was shocked to find the panel did not include a radiation oncologist. “Even the voice of my doctor, who is probably one of the top three in his field worldwide, was being totally muted.”

After a number of reviews and appeals and countless phone calls, the treatment was finally approved but it had taken six weeks and many headaches.

Being in the room

His experiences have made him realise the importance of the patient voice being front and centre of healthcare decisions.

“I want to be in the room where it happens, where the decisions are made, so that it’s not just me, a passive patient sitting in the chemo suite,” he said.

“That means working with pharma companies to influence early decisions around R&D, and providing patient insights throughout the process.”

We also need to think about how other stakeholders – insurance companies, doctors, and hospitals, for example – fit into that, said Robert.

“My broad ambition is to get medicines and medical solutions that are more accessible, more affordable, and available in a more timely, more patient friendly way.”

Explaining why patients were an essential part of that mission, he said: “Everyone is driven by different goals and different stakeholders will have different drivers of what’s important.”

Levelling up

Robert, who works with several pharma companies on a variety of projects, believes that the industry is going in the right direction, but that there is still some way to go.

He described three levels of patient engagement, saying most organisations were currently “between one and two”.

“The first one is engaging the patient. That might call a patient or group of patients in to review a consent form or a trial protocol. They will ask them if it seems reasonable, feasible, or overly burdensome, then take those comments and say: ‘see you later’.”

The second level is more like a patient partnership, he said, using his position as member of one company’s Oncology Patient Council as an example.

“We meet once a month throughout the development cycle to provide feedback. We engage with them on challenges they might be facing, or on specific topics such as patient diversity. It’s a continuous process – a feedback loop – not a one-off interaction,” said Robert.

The next step is true patient centricity, which Robert described as “putting the patient at the centre of the wheel”.

“What that looks like in practice is ongoing involvement and engagement with the patient throughout,” he said, adding that it included making sure interventions were as easy to access geographically, logistically, and physically, as possible.

“It all goes back to this idea of being in the room. Of course, not all patients can be there, but if I can share the insights I have gained from my own journey, under the caveat that all patients are different, then at least they have heard what I have to say,” Robert concluded.


inspirePatient Insights is a monthly series that appears in partnership with Inspire, a company with an online support community of more than 2 million patients and caregivers worldwide.

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AZ’s Q3 results disappoint – but COVID19 vaccine trial is still on track

AstraZeneca has posted an uninspiring set of quarterly results as it gears up for results from its closely watched coronavirus vaccine trial.

AZ said in its third quarter results statement that it is on track to meet its guidance for the year, with total revenue expected to grow by 8%-12% and core earnings per share increasing by 15%-19%.

In the three months to the end of September AZ’s revenue increased by 3% to $6.6 billion, with products sales up 6%.

Earnings per share fell to $0.94, missing analysts’ estimates of $1, as some patients held off treatments for ailments unrelated to COVID-19.

AZ has pursued a strategy of selling off its older or unwanted drugs and has been benefiting from “collaboration revenue” from these deals as development partners reach certain milestones.

This revenue fell by 79% to $58 million compared with the same quarter last year, although the company said that this was down to a strong performance in last year’s Q3.

The company suggested that collaboration revenue may be higher in the next quarter as this income tends to come in chunks as various research projects reach fruition or sales targets are met.

At the same time the company also grabbed two new European approvals – for Lynparza in castration-resistant prostate cancer and for Forxiga for a form chronic heart failure.

The company’s coronavirus vaccine is perhaps the company’s most eagerly-watched pipeline asset, although AZ is unlikely to make much money from it – at least until the worst of the pandemic is over.

As reported by pharmaphorum earlier this week, AZ expects results from its late-stage trial by the end of the year despite a safety scare in September, setting up approval by regulators early in 2021.

AZ has pledged to sell the vaccine at cost price until a cut-off point expected midway through next year.

But as the UK heads for another economically damaging month-long lockdown the company confirmed that it could have crucial phase 3 data from the vaccine by the end of the year.

If approved the vaccine will do little for the company’s figures but will create huge goodwill as governments across the world seek an end to the spiral of death caused by the coronavirus.

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FDA Extends RCA With COTA to Explore COVID’s Effect on Cancer

What You Should Know:

– The FDA just extended its research collaboration
agreement (RCA) with COTA, specifically looking at how COVID-19 is affecting
cancer.

– With this expanded agreement, COTA and the FDA will use real-world data to explore the impact of COVID-19 and the pandemic on cancer treatment, with the opportunity to expand into other oncology questions in the future.


COTA, Inc., a healthcare technology
company that uses real-world data to bring clarity to cancer care, today
announced it has extended its Research Collaboration Agreement (RCA) with the
U.S. Food and Drug Administration (FDA) for an additional three years. This
renewed RCA will expand on the objective to explore the applications of
real-world data in oncology, including the impact of COVID-19 and the
pandemic on cancer treatment. As the project advances, the research will
broaden to study other oncology care delivery questions.

Real-world data can provide critical insights into the
delivery of cancer treatment in the routine practice setting, as well as
potential long-term effects post-COVID-19 recovery. The expanded focus of this
RCA will enable the exploration of important research questions to help support
FDA’s understanding of how the COVID-19 pandemic continues to impact patients
with cancer.

Why It Matters

With over 8 million cases of COVID-19 in the United States,
there is a significant need to understand the pandemic’s impact on oncology
care. Additionally, an increasing body
of research
 has shown that oncology patients may be particularly
susceptible to harm during this pandemic – both in contracting the
condition itself
 or experiencing care delays.

Cancer patients are particularly at risk of severe complications with COVID-19, and there is currently no understanding of how this can affect their oncology care or progression. Through real-world data, we can begin to understand if COVID-19 should be considered as comorbidity – particularly around clinical trial criteria.

Europe approves Roche’s Tecentriq liver cancer combination

The European Commission has approved Roche’s Tecentriq immunotherapy, in combination with its established cancer drug Avastin, for patients with the most common form of liver cancer.

Tecentriq (atezolizumab) can be used with Avastin (bevacizumab) for adults with advanced or unresectable hepatocellular carcinoma (HCC) who have not received systemic therapy.

Approval is based on findings of the phase 3 IMbrave 150 study, which showed an improvement in overall survival compared with Bayer’s Nexavar (sorafenib), which has long been the standard of care in liver cancer.

The study showed that Tecentriq in combination with Avastin reduced risk of death by 42% and reduced risk of disease worsening or death by 41% compared with Nexavar.

This result was the first time that a phase 3 cancer immunotherapy showed an improvement over Nexavar in both overall survival and progression-free survival.

Grade 3–4 adverse events occurred in 57% of people receiving Tecentriq and Avastin and 55% of people receiving sorafenib.

The most frequent serious adverse reactions for the combination, occurring in 2% or more of patients, were bleeding in the gastrointestinal tract and fever.

The decision follows approval of the combination therapy from the FDA in May, and from China’s National Medical Products Administration last month, although the latter decision only applied to untreated patients with unresectable disease.

Tecentriq is becoming increasingly important to Roche as sales of its “big three” cancer drugs Avastin, Herceptin, and Rituxan/MabThera fall away because of competition from cheaper biosimilars.

Sales of Tecentriq were up 64% in the first nine months of this year to just over 2 billion swiss francs ($2.2 billion), making it one of the company’s fastest growing products, and the fastest growing excluding recently launched products.

A PD-L1 class checkpoint inhibitor, Tecentriq works by calling in an attack from the patient’s immune system and since hitting the market in 2016 has already picked up US approvals in a range of oncology indications including lung and bladder cancer.

The big Swiss pharma is also developing it for several other types of lung, genitourinary, skin, breast, gynaecological and head and neck cancers.

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Novartis Reports Results of Kisqali (ribociclib) in P-III MONALEESA-7 Study in Women with HR+/HER2- Advanced Breast Cancer

Shots:

  • The pivotal P-III MONALEESA-7 study assessing Kisqali + endocrine therapy vs PBO + endocrine therapy, in pre- & perimenopausal women with HR+/HER2- advanced or metastatic-BC
  • The study met its 2EPs of OS, demonstrating a significant improvement in OS, and is consistent for the NSAI population & across exploratory subgroups, m-OS was not reached while the median duration of follow-up was 34.6 mos.
  • Kisqali is a selective cyclin-dependent kinase inhibitor, acts by inhibiting two proteins called CDK4/6

Click here ­to­ read full press release/ article | Ref: Novartis | Image: Law

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Jounce shares crash after it abandons immunotherapy combination trial

Shares in Jounce Therapeutics are down sharply after it emerged that its immunotherapy combination with Bristol-Myers Squibb’s Yervoy will likely fail to produce results in non-small cell lung cancer.

Jounce was combining its vopratelimab with BMS’ already-approved Yervoy, hoping that the experimental drug will bolster the T-cell attack called in by the big pharma’s immunotherapy.

But an early look at the data from the phase 2 EMERGE trial showed that the combination is unlikely to work in a group of patients already treated with a PD-1 or PD-L1 immunotherapy such as Merck & Co’s Keytruda.

Results from the 22 patients treated with the highest dose of vopratelimab in combination with Yervoy showed only one patient with a confirmed overall response based on standard criteria, although tumours did seem to shrink in 12 patients.

There were no confirmed responses in two other arms of 18 and 10 patients respectively treated with a lower dose of vopratelimab in combination with Yervoy.

Only nine patients remained on the study, including four patients continuing to benefit from vopratelimab alone with an overall survival across all groups of 11.6 months across all groups.

The data were short of the criteria to expand the trial requiring tumour reduction in at least 50% of patients, overall survival above 13 months and an overall response rate of 10% or above.

As a result the EMERGE trial will not be expanded, the company said, although the first patient has been dosed in the SELECT phase 2 trial, supporting vopratelimab in combination with the company’s own JTX-4014 in certain NSCLC patients untreated with immunotherapy.

EMERGE was testing the hypothesis that vopratelimab could swell the numbers of ICOS hi CD4 cells that are called in by Yervoy to attack tumours.

Shares in Jounce were down more than 18% on the Nasdaq following the announcement.

Jounce does have other strings to its bow however – in September it announced a deal with Gilead to develop another immunotherapy called JTX-1811.

This targets T-cells that have been taken over by tumours and suppress attacks from the immune system, and could be worth more than $800 million if trials work out.

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AstraZeneca and Fusion Collaborate to Develop and Commercialize Radiopharmaceuticals and Combination Therapies for Cancer

Shots:

  • Fusion to receive up front, as well as development milestones and other payments. The companies will jointly discover, develop, and have an option to co-commercialize novel TATs in the US while AstraZeneca will lead commercialization in the ROW with equal profit & loss sharing globally
  • The collaboration leverages Fusion’s TAT platform and expertise in radiopharmaceuticals with AstraZeneca’s leading portfolio of Abs and cancer therapies, including DDRis
  • Additionally, the companies will exclusively explore certain specified combination strategies between TATs (including Fusion’s FPI-1434) and AstraZeneca’s therapies for the treatment of multiple cancers. Both companies will retain full rights to their respective assets

Click here to­ read the full press release/ article | Ref: Fusion Pharmaceuticals | Image: Moffitt

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Sanofi to acquire Kiadis and NK cell tech for $353 million

Sanofi is to acquire Kiadis, a biotech specialising in therapies based around ‘off the shelf’ natural killer (NK) cells, for 308 million euros ($353 million).

The French pharma is buying Kiadis for 5.45 euros per share in cash, an offer price representing a premium of 272% over the biotech’s closing price on Friday evening on Amsterdam’s Euronext market.

It’s a substantial price to pay for the small pharma. Although the company’s share price has been notoriously volatile, the NK-cell technology is still largely unproven in clinic.

Allogeneic, or ‘off the shelf’, cell therapies are derived from banks of cells, and potentially offer the therapeutic benefits seen with autologous cell therapies derived from a patient’s own bodies but without the complex, costly and lengthy manufacturing process.

Autologous CAR-T cancer therapies based on T-cells are already on the market from Novartis and Gilead, but have had a slow start in terms of sales as health systems struggled to come to terms with their high price and the logistics of manufacturing them and delivering them to patients.

While Kiadis’ technology is mainly intended for cancer, the biotech announced plans in August to develop a NK-cell therapy for COVID-19, sending its shares soaring before they fell back due to profit-taking.

This followed a separate deal with Sanofi in July, where the pharma licensed Kiadis’ pre-clinical drug K-NK004 for multiple myeloma.

Kiadis has K-NK002 in phase 2 development to prevent patients with acute myeloid leukaemia (AML) and myelodysplastic syndromes from relapsing after transplant.

Also in phase 1 development is K-NK003, for patients with relapsed or refractory AML.

Kiadis is drawing up plans to begin a phase 1/2a clinical trial of KNK-ID-101, its COVID-19 therapy in high risk patients, with funding from the French government.

Acquiring Kiadis outright makes sense for Sanofi, which already has a foothold in cancer immunotherapy thanks to its Libtayo (cemiplimab), developed in partnership with Regeneron and already approved in a form of skin cancer.

Shareholders in Kiadis will likely be pleased with the substantial premium agreed and the deal has the unanimous support of its board.

Funds managed by Life Sciences Partners have committed to support the offer, accounting for 18.3% of shares in the Netherlands-based biotech.

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GSK’s Zejula (niraparib) Receives EC’s Approval as a Treatment in Advanced Ovarian Cancer

Shots:

  • The approval is based on PRIMA study assessing Zejula (300mg qd), later amended to incorporate an individualised starting dose of Zejula (200 mg or 300 mg, qd) based on the patient’s baseline weight and/or platelet count
  • Results: The PRIMA study improved PFS for patients treated with Zejula, regardless of biomarker status. In the HRd population, Zejula reduced the risk of disease progression or death vs. pbo by 57% and the risk of disease progression or death vs. pbo by 38% in the overall population. Additionally, risk of progression in those with BRCA mutation tumours showed 60% reduction
  • Zejula is an oral, once-daily PARP inhibitor that is currently being evaluated in multiple pivotal trials. It is the first PARP inhibitor approved as monotherapy in the EU for patients with platinum-responsive advanced ovarian cancer

Click here to­ read the full press release/ article | Ref: Abbvie | Image: Spiegel

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ANGLE raises £20m, eyes opportunity in immunotherapy trials

Liquid biopsy company ANGLE has raised £20m through a conditional placing on the London Stock Exchange which will be used to expand commercial opportunities.

ANGLE’s Parsortix system detects and captures circulating tumour cells (CTCs) in blood for subsequent analysis. The company believes there is huge potential for its use in assessing patient response to immunotherapy drugs.

“This raise enables us to set up two clinical laboratories for pharma services and processing patient samples. It also enables us to do some development of new assays, particularly for PD-L1 checkpoint inhibitors,” ANGLE CEO, Andrew Newland told pharmaphorum.

A study by the Laboratory of Translational Oncology, School of Medicine, University of Crete, demonstrated the system can predict patient response to immunotherapy. Results showed the detection of Indolamine-2,3-dioxygenase IDO and CTCs, particularly the IDO+/PD-L1- CTC subpopulation harvested using Parsortix, was significantly associated with reduced progression-free survival and overall survival in NSCLC patients treated with anti-PD-1 agents.

“The immunotherapy market is currently generating revenue of $22bn and growing at 40% per year. With thousands of active clinical trials focused on PDL checkpoint 1 inhibitors, we believe every single one of those trials could benefit from using Parsortix for CTC analysis and PDL1 expression,” Newland said. “This is an exciting opportunity as this market is not dependent on us receiving clearance.”

ANGLE submitted a full De Novo FDA application for Parsortix in September. The system could be the first medical device to receive FDA clearance for harvesting intact CTCs from the blood of metastatic breast cancer patients.

According to Newland, the £20m raise attracted more US investors as the appetite for liquid biopsy increases. “There is a consensus amongst US investment bankers that the liquid biopsy market is going to be over $100 billion a year per year in the US alone. We are seeing much more interest from US investors because they see us as a very undervalued opportunity in this space. They see we have solutions that can expand what liquid biopsy companies are doing and we don’t have to compete with them.”

The liquid biopsy space has exploded this year as companies signed billion-dollar deals to strengthen their market positions. Illumina announced a $8 billion agreement to reacquire former spinout Grail and Exact Sciences entered a $2.15 billion deal to buy Thrive.

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What White Blood Cell Count Should We Shoot for?

At the start of my video What Does a Low White Blood Cell Count Mean?, you can see what it looks like when you take a drop of blood, smear it between two pieces of glass, and view at it under a microscope: a whole bunch of little, round, red blood cells and a few big, white blood cells. Red blood cells carry oxygen, while white blood cells are our immune system’s foot soldiers. We may churn out 50 billion new white blood cells a day. In response to inflammation or infection, that number can shoot up to a 100 billion or more. In fact, pus is largely composed of: millions and millions of white blood cells.

Testing to find out how many white blood cells we have at any given time is one of the most common laboratory tests doctors order. It’s ordered it hundreds of millions of times a year. If, for example, you end up in the emergency room with abdominal pain, having a white blood cell count above about 10 billion per quart of blood may be a sign you have appendicitis. Most Americans fall between 4.5 and 10, but most Americans are unhealthy. Just because 4.5 to 10 is typical doesn’t mean it’s ideal. It’s like having a “normal” cholesterol level in a society where it’s normal to die of heart disease, our number-one killer. The average American is overweight, so if your weight is “normal,” that’s actually a bad thing.

In fact, having excess fat itself causes inflammation within the body, so it’s no surprise that those who are obese walk around with two billion more white cells per quart of blood. Given that, perhaps obese individuals should have their own “normal” values. As you can see at 2:06 in my video, if someone with a 47-inch waist walks into the ER with a white blood cell count of 12, 13, or even 14, they may not have appendicitis or an infection. That may just be their normal baseline level, given all the inflammation they have in their body from the excess fat. So, normal levels are not necessarily healthy levels.

It’s like smoking. As you can see at 2:31 in my video, if you test identical twins and one smokes but the other doesn’t, the smoker is going to end up with a significantly higher white cell count. In Japan, for example, as smoking rates have steadily dropped, so has the normal white count range. In fact, it’s dropped such that about 8 percent of men who have never smoked would now be flagged as having abnormally low white counts if you used a cut-off of 4. But, when that cut-off of 4 was set, most people were smoking. So, maybe 3 would be a better lower limit. The inflammation caused by smoking may actually be one of the reasons cigarettes increase the risk of heart attacks, strokes, and other inflammatory diseases. So, do people who have lower white counts have less heart disease, cancer, and overall mortality? Yes, yes, and yes. People with lower white blood cell counts live longer. Even within the normal range, every one point drop may be associated with a 20 percent drop in the risk of premature death.

As you can see at 3:39 in my video, there is an exponential increase in risk in men as white count goes up, even within the so-called normal range, and the same is found for women. The white blood cell count is a “stable, well-standardized, widely available and inexpensive measure of systemic inflammation.” In one study, half of the women around 85 years of age who had started out with white counts under 5.6 were still alive, whereas 80 percent of those who started out over 7 were dead, as you can see at 4:05 in my video—and white blood cell counts of 7, 8, 9, or even 10 would be considered normal. Being at the high end of the normal range may place one at three times the risk of dying from heart disease compared to being at the lower end.

The same link has been found for African-American men and women, found for those in middle age, found at age 75, found at age 85, and found even in our 20s and 30s: a 17 percent increase in coronary artery disease incidence for each single point higher.

As you can see at 5:00 in my video, the higher your white count, the worse your arterial function may be and the stiffer your arteries may be, so it’s no wonder white blood cell count is a useful predictor of high blood pressure and artery disease in your heart, brain, legs, and neck. Even diabetes? Yes, even diabetes, based on a compilation of 20 different studies. In fact, it may be associated with everything from fatty liver disease to having an enlarged prostate. And, having a higher white blood cell count is also associated with an increased risk of dying from cancer. So, what would the ideal range be? I cover that in my video What Is the Ideal White Blood Cell Count?.

A higher white blood cell count may be an important predictor for cardiovascular disease incidence and mortality, decline in lung function, cancer mortality, all-cause mortality, heart attacks, strokes, and premature death in general. This is no surprise, as the number of white blood cells we have circulating in our bloodstreams are a marker of systemic inflammation. Our bodies produce more white blood cells day to day in response to inflammatory insults.

We’ve known about this link between higher white counts and heart attacks since the 1970s, when we found that higher heart attack risk was associated with higher white blood cell counts, higher cholesterol levels, and higher blood pressures, as you can see at 0:53 in my video What Is the Ideal White Blood Cell Count?. This has been found in nearly every study done since then. There are decades of studies involving hundreds of thousands of patients showing dramatically higher mortality rates in those with higher white counts. But why? Why does white blood cell count predict mortality? It may be because it’s a marker of inflammation and oxidation in the body. In fact, it may even be a biomarker for how fast we are aging. It may be more than just an indicator of inflammation—it may also be an active player, contributing directly to disease via a variety of mechanisms, including the actual obstruction of blood flow.

The average diameter of a white blood cell is about seven and a half micrometers, whereas our tiniest vessels are only about five micrometers wide, so the white blood cell has to squish down into a sausage shape in order to squeeze through. When there’s inflammation present, these cells can get sticky. As you can see at 2:20 in my video, a white blood cell may plug up a vessel as it exits a small artery and tries to squeeze into a capillary, slowing down or even momentarily stopping blood flow. And, if it gets stuck there, it can end up releasing all of its internal weaponry, which is normally reserved for microbial invaders, and damage our blood vessels. This may be why in the days leading up to a stroke or heart attack, you may find a spike in the white cell count.

Whether white count is just a marker of inflammation or an active participant, it’s better to be on the low side. How can we reduce the level of inflammation in our body? Staying away from even second-hand smoke can help drop your white count about half of a point. Those who exercise also appear to have an advantage, but you don’t know if it’s cause and effect unless you put it to the test. In one study, two months of Zumba classes—just one or two hours a week—led to about a point and a half drop in white count. In fact, that may be one of the reasons exercise is so protective. But is that just because they lost weight?

Fitness and fatness both appear to play a role. More than half of obese persons with low fitness—51.5 percent—have white counts above 6.6, but those who are more fit or who have less fat are less likely to have counts that high, as you can see at 3:47 in my video. Of course, that could just be because exercisers and leaner individuals are eating healthier, less inflammatory diets. How do we know excess body fat itself increases inflammation, increases the white count? You’d have to find some way to get people to lose weight without changing their diet or exercise habit. How’s that possible? Liposuction. If you suck about a quart of fat out of people, you can significantly drop their white count by about a point. Perhaps this should get us to rethink the so-called normal reference range for white blood cell counts. Indeed, maybe we should revise it downward, like we’ve done for cholesterol and triglycerides.

Until now, we’ve based normal values on people who might be harboring significant background inflammatory disease. But, if we restrict it to those with normal C-reactive protein, another indicator of inflammation, then instead of “normal” being 4.5 to 10, perhaps we should revise it closer to 3 to 9.

Where do the healthiest populations fall, those not suffering from the ravages of chronic inflammatory diseases, like heart disease and common cancers? Populations eating diets centered around whole plant foods average about 5, whereas it was closer to 7 or 8 in the United States at the time. How do we know it isn’t just genetic? As you can see at 5:38 in my video, if you take those living on traditional rural African diets, who have white blood cell counts down around 4 or 5, and move them to Britain, they end up closer to 6, 7, or even 8. Ironically, the researchers thought this was a good thing, referring to the lower white counts on the “uncivilized” diet as neutropenic, meaning having too few white blood cells. They noted that during an infection or pregnancy, when more white cells are needed, the white count came right up to wherever was necessary. So, the bone marrow of those eating traditional plant-based diets had the capacity to create as many white cells as needed but “suffers from understimulation.”

As you can see at 6:26 in my video, similar findings were reported in Western plant eaters, with an apparent stepwise drop in white count as diets got more and more plant based, but could there be non-dietary factors, such as lower smoking rates, in those eating more healthfully? What we need is an interventional trial to put it to the test, and we got one: Just 21 days of removing meat, eggs, dairy, alcohol, and junk affected a significant drop in white count, even in people who started out down at 5.7.

What about patients with rheumatoid arthritis who started out even higher, up around 7? As you can see at 7:03 in my video, there was no change in the control group who didn’t change their diet, but there was a 1.5 point drop within one month on whole food plant-based nutrition. That’s a 20 percent drop. That’s more than the drop-in inflammation one might get quitting a 28-year pack-a-day smoking habit. The most extraordinary drop I’ve seen was in a study of 35 asthmatics. After four months of a whole food plant-based diet, their average white count dropped nearly 60 percent, from around 12 down to 5, though there was no control group nor enough patients to achieve statistical significance.

If white blood cell count is such a clear predictor of mortality and is so inexpensive, reliable, and available, why isn’t it used more often for diagnosis and prognosis? Maybe it’s a little too inexpensive. The industry seems more interested in fancy new risk factors it can bill for.

I touch on the health of the rural Africans I discussed in How Not to Die from Heart Disease.


For more on fighting inflammation, see:

In health,

Michael Greger, M.D.

PS: If you haven’t yet, you can subscribe to my free videos here and watch my live presentations:

Exact Sciences buys cancer detection company Thrive for $2.15 billion

Stocks for Exact Sciences leaped 33% after it announced the acquisition of liquid biopsy rival Thrive and UK start-up Base Genomics.

Exact Sciences said it has agreed to buy Thrive for a cash and stock deal worth up to $2.15 billion, positioning it as a leader in the cancer-screening market.

The Madison-based company has made no secret of its ambitions to become the top player in the liquid biopsy space.

Thrive’s technology has attracted excitement from investors since it spun out of Johns Hopkins University. In July 2020, the company closed a $257m series B funding round, led by Casdin Capital and Section 32.

The CancerSEEK blood test is designed to detect multiple cancers by analysing tumour specific genomic mutations in circulating tumor DNA (ctDNA) and cancer-associated protein biomarkers in plasma. These are then analysed by machine learning algorithms.

The company’s DETECT-A study was the first-ever prospective, interventional study of a multi-cancer blood test. Key findings from the study showed CancerSEEK had a specificity of 99.6% and identified cancer in individuals without a history of the disease. The study was hailed by Thrive as a “seminal moment” in cancer screening.

Exact Sciences, which is behind brands Cologuard and Oncotype DX, said it will combine CancerSEEK with its scientific platform, clinical organization, and commercial infrastructure. The company also announced the acquisition of Base Genomics, a UK epigenetics start-up for $410m. The start-up uses DNA methylation analysis to detect cancer in its early stages.

Exact Sciences Cologuard business also received a boost from updated guidelines released by the United States Preventive Services Task Force. The draft recommended colorectal cancer screening should now begin at age 45 and recommends Exact Sciences’ Cologuard as a screening method for all average-risk patients between the ages of 45 and 75.

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Toxic positivity and grief: The reality of living through cancer

Cancer doesn’t end when treatment stops – it’s a lifelong journey and people need support throughout, says patient advocate Megan-Claire Chase.

No one gets through cancer unscathed. People are usually left with a mixture of treatment aftereffects, toxic positivity, and lingering anger to deal with.

Megan-Claire Chase, a fierce patient advocate who has been blogging about her experiences since she was diagnosed with breast cancer in 2015, said the disease never went away.

“Sometimes, people feel that once you finish your treatment, you are done, and you should stop talking about it. But really, it has only just begun. It is a lifelong journey.

“We’re going to need to have scans forever and we’ve been traumatised by the whole experience, so it’s hurtful when your family members and your friends think you should just move past it.”

Megan-Claire underwent 16 rounds of chemotherapy, nine operations, and 33 radiation treatments after developing invasive lobular breast cancer in her  30s.

As a result of the treatment, she is infertile, has chemo-induced fibromyalgia and neuropathy in her hands and feet. She goes to the cancer center for a diagnostic mammogram and rotates between getting an MRI and ultrasound every six months for 10 years.

“You know that people have good intentions and they are coming from a good place, but when your family and friends just want to see you smiling all the time, it can feel like you’re putting on an act”

Quality of life after cancer

There are a lot of quality of life issues, many of which were not understood outside of the cancer community, says Megan-Claire.

She says: “Sometimes I have to walk with a cane. Because of the neuropathy on my feet, I can’t walk very long distances because the numbness goes up my leg and I fall over and hurt myself.

“That’s what I want people to understand. Some people are on active treatment forever. For others, that treatment has a stopping point, but even then, there are all these other issues that can stem from the poison that goes into your body.”

News stories about cancer survivors going on to achieve great feats of endurance do nothing to help the public perception of what it means to live with the long-term effects of the disease and its treatments.

“Some people are able to climb mountains and do walks and all of that physical stuff. But for others that ability was taken away and it feels like yet another loss,” says Megan-Claire:

“We’re constantly grieving – grieving the loss of the body parts that are missing, the physical abilities we had, and, for many of us, grieving the jobs we used to have before we had to stop working.

“We also have to grieve the friends we have made and lost along the way. We’re constantly reminded of our mortality and have to live with the fear that it could come back at any time.”

Releasing the negative

Through her blog, Life on the Cancer Train, and her advocacy work, Megan-Claire meets many young people in a similar position to her. She believes it helps to give them the space to own their feelings and share their experiences with others who truly understand the nuances of life after cancer.

“When I write, I write what is on my mind, but I always find that resonates with people. A lot of people are hurting, and I think it helps that I post about the elephants in the room: the mental health issues, the anger, the post-traumatic stress disorder,” says Megan-Claire. “People need a place to release all that.”

‘Toxic positivity’ is another issue people who have been through cancer treatment commonly face and dealing with it head on can be extremely difficult, Megan-Claire explains.

“It’s impossible to be this tower of strength all the time. A lot of us get annoyed when we are told: ‘Oh, you’re so brave’, or ‘I don’t know how you do it’. When that happens, all I’m thinking is ‘Do I want to live or do I want to die. It’s not a fair choice.’

“You know that people have good intentions and they are coming from a good place, but when your family and friends just want to see you smiling all the time, it can feel like you’re putting on an act.”

Peer support

What people need, she went on, was a place where they could “take off the mask and just be vulnerable”. And that’s where peer support comes in.

“Cancer support groups are a safe place where people can meet and talk about their experiences with no judgement.“” says Megan-Claire, who belongs to several young adult cancer groups online.

“My advice to people is always: if you’re angry, be angry. If you’re sad, be sad. Just don’t wallow in it forever. We need to feel these emotions so we can move through them and then do what it is we need to do to move forward with our lives.”

To read Megan-Claire’s blog, click here. See our last interview with Megan-Claire here.


inspirePatient Insights is a monthly series that appears in partnership with Inspire, a company with an online support community of more than 1.5 million patients and caregivers worldwide.

The post Toxic positivity and grief: The reality of living through cancer appeared first on .

FDA Grants AppliedVR Breakthrough Designation for Virtual Reality Chronic Pain Treatment

FDA Grants AppliedVR Breakthrough Designation for Virtual Reality Chronic Pain Treatment

What You Should Know:

– FDA awards AppliedVR Breakthrough Device designation for
treating treatment-resistant fibromyalgia and chronic intractable lower back
pain

– AppliedVR’s EaseVRx program helps patients learn self-management skills grounded in evidence-based cognitive-behavioral therapy (CBT) principles and other behavioral methods.


AppliedVR,
a pioneer advancing the next generation of digital medicine, today announced
its EaseVRx product received Breakthrough Device designation from the U.S. Food
and Drug Administration (FDA) for treating treatment-resistant fibromyalgia and
chronic intractable lower back pain. EaseVRx is now one of the first virtual
reality (VR) digital therapeutics to get breakthrough designation to treat
conditions related to chronic pain.

What is the FDA Breakthrough Device Program?

The FDA Breakthrough Device Program helps patients receive more timely access to breakthrough technologies that could provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions. 

Clinical Trial Results/Outcomes

AppliedVR achieved this milestone after successfully
completing the first randomized controlled trial (RCT), evaluating VR-based
therapy for self-management of chronic pain at home. The RCT, which was
published in JMIR-FR,
found that a self-administered, skills-based VR treatment program for treating
chronic pain was feasible, scalable and was effective at improving on multiple
chronic pain outcomes – each of which met or exceeded the 30-percent threshold
to be clinically meaningful. On average, participants noted:

– Pain intensity reduced 30 percent;

– Pain-related activity interference reduced 37 percent;

– Pain-related mood interference reduced 50 percent;

– Pain-related sleep interference reduced 40 percent; and

– Pain-related stress interference reduced 49 percent.

EaseVRX Program Background

AppliedVR’s EaseVRx program helps patients learn self-management skills grounded in evidence-based cognitive-behavioral therapy (CBT) principles and other behavioral methods. The program was designed by AppliedVR, in partnership with the top pain experts and researchers, to improve self-regulation of cognitive, emotional, and physiological responses to stress and pain. AppliedVR has already been shown to be an effective treatment for acute pain in hospital settings

Why Virtual Reality Is An Effective Approach for Pain
Management

Lower back pain is one of the most common
chronic conditions that people face worldwide and represents one of the top
reasons why people miss work. Additionally, it’s an extremely
costly problem for insurers, especially as they look to cut costs related to back surgery. Recent research indicated that, when combined with neck pain,
lower back pain costs nearly $77 billion to private insurance, $45 billion to
public insurance, and $12 billion in out-of-pocket costs for patients.

Chronic pain more broadly also is a difficult and costly
problem that has contributed to many other major health problems in the U.S.,
including the opioid epidemic. A previous Johns Hopkins study in the Journal of
Pain found that chronic pain can cumulatively cost as high as $635 billion a year — more than the annual costs of
cancer, heart disease and diabetes — and lower back pain has been one of the most common reasons for prescribing opioids.
Cognitive behavioral therapies like VR are now seen by many providers as an
effective alternative or complement to pharmacological interventions that can
support their larger treatment tool belts.

“Since 1980, the American Chronic Pain Association has advocated a multidisciplinary approach to pain management—using a combination of medical and behavioral techniques to address pain,” said Penny Cowan, founder and CEO of the American Chronic Pain Association. “Virtual reality has the potential to be an important resource in this approach, helping people with pain to think differently about their conditions and learn strategies to reduce suffering and improve quality of life.”

Future Clinical Trials

AppliedVR is currently engaged in many other trials,
including feasibility studies with multiple well-known payers and with the
University of California at San Francisco (UCSF) to study how digital therapeutic platforms, including
virtual and augmented reality, can be used to improve care access for
underserved populations. AppliedVR also is advancing two clinical trials with
Geisinger and Cleveland Clinic to study VR as an opioid-sparing tool for acute
and chronic pain – specifically the company’s RelieVRx and EaseVRx platforms.
The National Institute on Drug Abuse (NIDA), part of the National Institutes of
Health (NIH), recently awarded $2.9 million grants to fund the trials.

JPC Taps Proscia to Modernize World’s Largest Human Tissue Repository

JPC Taps Proscia to Modernize World's Largest Human Tissue Repository

What You Should Know:

– The U.S. government’s Joint Pathology Center, which
houses the world’s largest human tissue repository, today announced that
Proscia, a leading digital and AI pathology company, will provide end-to-end
modernization of JPC’s pathology operations.

– The multi-phase project will digitize the world’s
largest human pathology specimen repository in order to enhance biomedical
research for cancer and infectious diseases like COVID-19, and enable easier
data sharing with researchers, diagnosticians, and educators to facilitate
medical advances.

– The digitization of JPC’s repository will also unlock
previously untapped medical data in order to accelerate the development of
AI-powered pathology applications for building personalized therapeutics.


Joint Pathology Center (JPC),
the premiere pathology reference center for the U.S. government, has selected Proscia’s Concentriq platform
for a complete transformation of its pathology practice.  Proscia is a Philadelphia,
PA-based provider of digital and computational pathology solutions.

Modernize World’s Largest Human Tissue Repository

The Joint Pathology Center seeks to preserve, modernize, and
grow the nation’s oldest tissue repository to promote biomedical research. Over
the past century, it has collected approximately 55 million glass slides, 31
million paraffin-embedded tissue blocks, and over 500,000 wet tissue samples,
which have provided critical insight into our understanding of current and
future disease; data from the repository was used to sequence the 1918
influenza virus that killed more than 40 million people worldwide and can
similarly help us to combat COVID-19. The
rise of digital pathology, which captures high-resolution images of tissue
specimen, is enabling JPC to realize even more value from its data by making it
readily accessible to clinicians, pathologists, and healthcare data analysts.
Digital pathology also gives way to the introduction of computational pathology
applications leveraging artificial intelligence to unlock new insights that
drive drug discovery and routine diagnosis.

At the center of this modernization effort, JPC will
digitize its tissue archive, the world’s largest repository of human pathology
specimen, to capitalize on this invaluable source of medical data. The digital
repository will provide increased access to data for driving medical advances
related to infectious diseases and cancer as well as accelerate the development
of computational pathology applications establishing diagnosis, prognosis, and
personalized therapies for patients.

Proscia’s Concentriq Platform to Serve As Foundation for
Digital and Computational Pathology

As digitizing the world’s largest human tissue archive
depends on scalable software infrastructure, JPC has selected Proscia’s Concentriq digital and
computational pathology platform to provide this foundation. Concentriq is a
singular image and data management platform that unifies pathology operations
across the connected enterprise and accelerates workflows. With Concentriq, JPC
will provide its network of researchers with intuitive, secure access to its
data and streamline collaboration, enabling them to more easily analyze
thousands of diseases and find new ways to fight them. Additionally, JPC will
deploy Concentriq to digitize its routine pathology consultations and overcome
the delays that result from sharing physical specimen in an effort to improve
patient outcomes by providing accurate, timely pathology findings.

Why It Matters

Digitizing the repository also holds significant potential
for advancing the development of computational pathology applications spanning
diagnosis, prognosis, and personalized care. Training and validating even a
single application requires massive volumes of images to ensure that it can
account for the variability seen in practice, and JPC’s archive is unmatched in
its ability to provide this data for countless diseases and use cases. As JPC
delivers these applications, it can deploy them, along with other computational
solutions, into its research and clinical workflows leveraging Proscia’s
Concentriq.

“JPC’s modernization effort marks a monumental leap forward for the field of pathology, and we’re excited to be a part of it,” said David West, CEO of Proscia. “Concentriq sits at the intersection of digital and computational pathology across research and clinical practice, providing JPC with the tools needed to finally realize the full promise of its data and transform routine diagnosis.”

Blue Cross NC Launches No-Cost Virtual Programs to Quit Smoking and Reverse Diabetes

What You Should Know:

– Today, Blue Cross and Blue Shield of North Carolina partners
with Carrot Inc. and Virta Health to help address two of the largest ongoing
health issues facing Americans today – smoking and type 2 diabetes.

– Virta and Carrot’s programs will be available to
individual under-65 members and fully insured group members beginning November
2020.


Blue Cross and Blue Shield of North Carolina (Blue Cross NC), today announced it is teaming up with Carrot Inc. and Virta Health to launch no-cost virtual programs to help members quit smoking and reverse type 2 diabetes. Virta and Carrot’s programs will be available to individual under-65 members and fully insured group members beginning November 2020 at no cost. They support Blue Cross NC’s commitment to make health care better, simpler and more affordable by providing members easy access to care through digital technology

“We resolve to make whole person care a priority, and that means we have to think beyond treating conditions, and work to prevent and reverse them,” said Von Nguyen, vice president of clinical operations and innovations at Blue Cross NC. “We are excited to team up with Carrot and Virta and bring their innovative, life-changing programs directly to the homes of our members and address some of North Carolina’s most pressing health issues.”

Carrot’s Clinically-Proven Program Empowers People to
Quit Smoking 

In addition to being the leading cause of preventable death in the U.S., smoking remains a tremendous burden on our nation’s health care system. According to the Centers for Disease Control and Prevention, more than 16 million Americans are living with a disease caused by smoking, and for every person who dies because of smoking, at least 30 people live with a serious, smoking-related illness such as diabetes, COPD, heart disease, or cancer. Smoking-related illness costs the State of North Carolina over $13 billion every year.  

Carrot’s clinically-proven, app-based program Pivot, combines innovative technology, human-centered design, and behavioral science to empower people to quit smoking and remain non-smokers. In a recent clinical study 42 percent of participants achieved a successful quit over the course of the study, and seven months after the onset of the study, 86 percent of those who quit were smoke-free.

Pivot’s digital solution includes text-based access to
trained tobacco experts, a first-of-its-kind personal breath sensor to track
progress, nicotine therapy products, and access to Pivot’s online community for
collective wisdom and inspiration.  

“Carrot is excited to collaborate with Blue Cross NC to ease the burden smoking has long placed on the state of North Carolina and the American health care system,” said David S. Utley, M.D., CEO of Carrot Inc. “Quitting smoking is hard – every year, millions try to stop smoking. We’re proud to bring Pivot to the hundreds of thousands of Blue Cross NC members who want to live life tobacco free and help them prevent or reverse the severity of chronic conditions like diabetes, heart disease and COPD.”

Diabetes Reversal with Virta Health
More than 3.7 million people in North Carolina—nearly half of the adult
population—have either prediabetes or type 2 diabetes.  According to the
CDC, diabetes increases the risk for severe illness for those with COVID-19.

Virta Health, the leader in type 2 diabetes reversal, uses an innovative virtual care model that helps patients achieve normal blood sugar while eliminating the need for diabetes-specific medications. Patients receive near-real-time access to board-certified physicians and health coaches who provide expert, individualized guidance on nutrition and behavioral change through the Virta app. Virta also serves as a partner to Primary Care Providers, integrating its specialized diabetes reversal treatment into existing care plans.

In Virta’s peer-reviewed clinical outcomes, at one year 94
percent of participants reduced or eliminated the need for insulin. The
majority of patients eliminated all diabetes-specific prescriptions while
achieving normal blood sugar. Results also include 12 percent (30lbs) weight
loss, and improvement in over 20 markers of cardiovascular health, including
blood pressure.

“This is a massive opportunity to change the direction of health of an entire state, save lives, and significantly reduce healthcare spend along the way,” said Sami Inkinen, Virta Health co-founder and CEO. “Our collaboration with Blue Cross NC provides strong optimism that we can solve the type 2 diabetes crisis our nation is facing.” 

What About the Trans Fat in Animal Fat?

The years of healthy life lost due to our consumption of trans fats are comparable to the impact of conditions like meningitis, cervical cancer, and multiple sclerosis. But, if “food zealots” get their wish in banning added trans fats, what’s next? I explore this in my video Banning Trans Fat in Processed Foods but Not Animal Fat.

Vested corporate interests rally around these kinds of slippery slope arguments to distract from the fact that people are dying. New York Mayor Bloomberg was decried as a “meddling nanny” for his trans fat ban and attempt to cap soft drink sizes. How dare he try to manipulate consumer choice! But isn’t that what the food industry has done? “Soft drink portion sizes have grown dramatically, along with Americans’ waistlines.” In 1950, a 12-ounce soda was the king-sized option. Now, it’s the kiddie size. Similarly, with trans fats, it was the industry that limited our choice by putting trans fats into everything without even telling us. Who’s the nanny now?

New York City finally won its trans fat fight, preserving its status as a public health leader. “For example, it took decades to achieve a national prohibition of lead paint, despite unequivocal evidence of harm,” but New York City’s Board of Health led the way, banning it “18 years before federal action.”

There’s irony in the slippery slope argument: First, they’ll come for your fries; next, they’ll come for your burger. After the trans fat oil ban, one of the only remaining sources of trans fat is in the meat itself. “Trans fats naturally exist in small amounts in the fat in meat and milk,” as I’ve discussed before in my video Trans Fat in Meat and Dairy. Before the trans fat ban, animal products only provided about one fifth of America’s trans fat intake, but since the U.S. trans fat ban exempts animal products, they will soon take over as the leading source. As you can see at 2:09 in Banning Trans Fat in Processed Foods but Not Animal Fat, now that added trans fats are banned in Denmark, for example, the only real trans fat exposure left is from animal products found in the U.S. dairy, beef, chicken fat, turkey meat, lunch meat, and hot dogs, with trace amounts in vegetable oils due to the refining process.

The question is: Are animal trans fats as bad as processed food trans fats? As you can see at 2:38 in my video, a compilation of randomized interventional trials found that they both make bad cholesterol go up and they both make good cholesterol go down. So, both animal trans fats and processed food trans fats make the ratio of bad to good cholesterol go up—which is bad. Therefore, all trans fats cause negative effects “irrespective of their origin.” The researchers suspect that also removing natural trans fats from the diet could prevent tens of thousands of heart attacks, but unlike processed foods, you can’t remove trans fats from milk and meat because trans fats are there naturally.

The livestock industry suggests that a little bit of their trans fats might not be too bad, but you saw the same everything-in-moderation argument coming from the Institute of Shortening and Edible Oils after industrial trans fats were first exposed as a threat. The bottom line is “that intake of all sources of trans fat should be minimized.” The trans fat in processed foods can be banned, and just adhering to the current dietary guidelines to restrict saturated fat intake, which is primarily found in meat and dairy, would automatically cut trans fat intake from animal fats.

The reason no progress may have been made on animal trans fat reduction in Denmark is because The Danish Nutrition Council that pushed for the trans fat ban was a joint initiative of The Danish Medical Association and The Danish Dairy Board. They recognized that “the economic support from The Danish Dairy Council could be perceived as problematic” from a scientific integrity point of view, but, not to worry—“The Danish Medical Association expanded the Executive Board and the funding members to also include the Danish pork industry, the Danish meat industry, The Poultry and Egg Council and The Danish Margarine Industry Association.”

If people want to eat trans fat, isn’t that their right? Yes, but only if they’re informed about the risks—yet The Food Industry Wants the Public Confused About Nutrition.

For more on the industry pushback, see my video Controversy Over the Trans Fat Ban.

There does not appear to be a safe level of exposure to trans fat—or to saturated fat or dietary cholesterol, for that matter. See Trans Fat, Saturated Fat, and Cholesterol: Tolerable Upper Intake of Zero.


If you find these videos about industry influence on public policy compelling, check out my many others, including:

Note that the concept of raising or lowering HDL (the so-called good cholesterol) playing a causal role in heart disease has come into question. See Coconut Oil and the Boost in HDL “Good” Cholesterol.

In health,

Michael Greger, M.D.

PS: If you haven’t yet, you can subscribe to my free videos here and watch my live presentations:

AstraZeneca’s Tagrisso (osimertinib) Receives the US FDA’s Priority Review for the Adjuvant Treatment of Patients with Early-Stage EGFR-Mutated Lung Cancer

Shots:

  • AstraZeneca’s Tagrisso has received sNDA’s acceptance and has been granted PR in the US for the adjuvant treatment of patients with early-stage (IB, II, and IIIA) EGFRm NSCLC after complete tumor resection with curative intent
  • The sNDA is based on the P-III ADAURA trial assessing Tagrisso (80mg, qd, PO) vs PBO for 3yrs. or until disease recurrence in the adjuvant treatment of 682 patients with stage IB, II, IIIA EGFRm NSCLC following complete tumour resection & adjuvant CT as indicated. Unprecedented results showed reduction in the risk of disease recurrence or death by 80% and improvement in DFS
  • Tagrisso is an irreversible EGFR-TKI with clinical activity against CNS metastases with its expected PDUFA date in Q1’21

Click here ­to­ read full press release/ article | Ref: AstraZeneca | Image: The Print

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FDA grants fast review for AstraZeneca’s Tagrisso in early-stage lung cancer

The FDA has granted a fast review for AstraZeneca’s Tagrisso oncology drug in certain patients with early-stage lung cancer.

Results from the phase 3 ADAURA trial were the talk of this year’s American Society of Clinical Oncology (ASCO) conference in summer and the regulator has granted a Priority Review for a label extension based on the results.

The FDA reserves these faster reviews, taking six months at the most instead of the standard ten-month timeframe, for medicines that demonstrate superior efficacy or safety for serious diseases.

ADAURA tested Tagrisso (osimertinib) in patients with early-stage (1B, II and III) epidermal growth factor receptor-mutated (EGFR) non-small cell lung cancer (NSCLC) after complete tumour removal.

Up to 30% of all patients diagnosed early with NSCLC in this patient group may be diagnosed early enough to have curative surgery, but disease recurrence is common and more than three quarters of patients diagnosed in Stage IIIA experience recurrence within five years.

ADAURA was halted early this year after Tagrisso showed “overwhelming efficacy” in this patient group.

In the trial Tagrisso reduced the risk of disease recurrence or death by 83% compared to placebo in patients with tumours that had spread locally but not to other parts of the body (stage II-IIIa), and who had surgery with the aim of completely removing the tumour and curing their cancer.

The drug also reduced disease-free survival by 79% in the overall trial population (stage 1b to IIIa), and after two years 89% of patients remained alive, compared to 53% of the placebo group.

It’s the first time that a targeted drug has shown an improvement in this group of patients in a large scale trial.

Approval will be another string in the bow for Tagrisso, which is already a blockbuster bringing in revenues of more than $1 billion per quarter for the UK pharma.

Tagrisso is a third-generation irreversible EGFR-tyrosine kinase inhibitor that was originally intended to treat patients with EGFR-mutated NSCLC after an older drug from that class has been rendered useless by a T790M mutation, which usually occurs after around 18 months of treatment.

But since this first FDA approval in 2015 it has also been licensed in first-line treatment in EGFR-mutated lung cancer, after outperforming AZ’s older EGFR drug Iressa (gefitinib) and Roche’s rival Tarceva (erlotinib) in the phase 3 FLAURA trial.

 

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COVID-19 tests prop up Roche as US biosimilars bite in Q3

Roche’s pharmaceutical revenues have been hit by falling sales in its pharma division in Q3 but a spike in demand for COVID-19 tests spared the Swiss company’s blushes.

Sales of its “big three” cancer drugs were all down considerably in Q3 as cheaper biosimilars gained market share in the US.

Avastin was down 30% compared with the same quarter last year, generating revenues of just under 1.2 billion Swiss francs ($1.3 billion)

There was a similar story with MabThera/Rituxan, which was down 33% to just over CHF 1 billion ($1.1 billion) for the quarter, and Herceptin’s sales dipped 38% to CHF 879 million ($947 million).

In the past three years Roche has enjoyed one of the most successful drug launches of all time with MS drug Ocrevus, but this has not been enough to offset the falling sales from these cancer drugs which at their peak generated yearly sales in excess of $20 billion.

All three are facing competition from several different biosimilars in the US, which have come to market over the last couple of years and after the cut price competitors hit the European market.

Biosimilars are near-copies of complex biologic drugs that are shown to be as safe and effective as the originator with a series of rigorous trials and tests.

They are not sold at the rock-bottom prices seen with generics of small molecules but can save health systems billions by undercutting the price of the expensive biologics.

Sales for the pharma division slipped 4% to just over CHF 11.1 billion ($11.95 billion) for the quarter.

Surging sales from the company’s diagnostics division, which has been busy because of demand for tests during the COVID-19 pandemic, meant that sales for the group were broadly flat in the quarter.

The diagnostics division saw an 18% increase in revenues to just under CHF 3.6 billion ($3.9 billion), meaning that at constant exchange rates the company’s sales were up 1$ to CHF 14.7 billion ($15.8 billion).

Overall the company saw strong sales in the first quarter followed by a COVID-19 related decline in Q2, with sales stabilising in Q3 thanks to stronger sales of new medicines and demand for coronavirus tests.

Confirming the company’s 2020 outlook, CEO Severin Schwan noted the FDA approvals for three new medicines: Enspryng and Evrysdi for rare diseases and the cancer medicine Gavreto.

Roche is also working with Regeneron on the REGN-COV2 antibody cocktail, which the FDA is reviewing for an Emergency Use Authorization for COVID-19.

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Fujifilm & Volpara Partner to Help Clinicians Determine Patient Breast Density

Fujifilm & Volpara Partner to Help Clinicians Determine Patient Breast Density

What You Should Know:

– FUJIFILM Medical Systems U.S.A., Inc. and Volpara
Solutions announced the extension of their partnership to provide mammography
facilities and clinicians with breast imaging solutions designed to improve
image quality, streamline workflow and accurately assess a patient’s breast
density.

– Building on a successful 6-year partnership, Fujifilm’s
customers using ASPIRE Cristalle with Digital Breast Tomosynthesis (DBT) now
have access to the latest innovations from Volpara’s Breast Health Platform.


FUJIFILM
Medical Systems U.S.A., Inc., 
a provider of diagnostic imaging
and medical informatics solutions, and Volpara Solutions, a
purpose-driven software company on a mission to prevent advanced-stage breast
cancer, today announced an expanded partnership to provide mammography
facilities and clinicians with breast imaging solutions designed to improve
image quality, streamline workflow and accurately assess a patient’s breast
density.

Building on a successful 6-year partnership, Fujifilm’s
customers using ASPIRE
Cristalle 
with Digital Breast Tomosynthesis (DBT) will now have access
to the latest innovations from Volpara’s Breast Health Platform. Volpara®Live!
helps reduce patient recalls due to poor image quality by giving mammographers
instant feedback on positioning and compression—which the FDA attributes as the
cause of most image deficiencies—for adjustment before the patient leaves the
room. Volpara Enterprise provides a comprehensive analysis of quality on
every mammogram and tomosynthesis image taken at the facility to identify
opportunities for improvement.

Early Detection is Critical to Breast Cancer Survival

Dense breast tissue is associated with an increased risk of developing breast cancer. Volpara’s  Enterprise includes a module that uses proprietary x-ray physics, AI, and machine learning to generate an accurate volumetric measure of breast composition. It provides a repeatable, consistent, and objective means of scoring breast density.

“Early detection is critical to breast cancer survival.  It’s essential that clinicians and patients have as many resources available to them to quickly and accurately find any possible signs of disease,” said Christine Murray, Women’s Health Product Manager, FUJIFILM Medical Systems U.S.A., Inc. “Fujifilm is thrilled to expand our relationship with Volpara Solutions to offer our customers the clinical decision-support tools they need to improve mammography quality and enhance patient care.”  

Model-based Strategy to Guide the Choice of Clinical Doses for ADC

Chemotherapy has been a powerful method for fighting cancer for decades. One of the most effective therapies available, it is also known for weakening the patient and causing harsh side effects like pain, nausea, and hair loss. This is because in its zeal to attack cancer cells, chemo also kills healthy cells.

Enter antibody-drug
conjugates (ADCs). This promising anti-cancer therapy is designed to
specifically target tumor cells, leaving the body’s healthy cells unharmed.
Developing safe and effective ADCs is not without its difficulties, though, and
more of those challenges need to be overcome before ADCs can replace the role
of chemotherapy.  

Pharmacokinetic-pharmacodynamic
(PKPD) scientists at the French pharmaceutical multinational Pierre Fabre are
doing their part. They have developed novel modelling and simulation-based
tools to guide the choice of the most promising safe and efficacious dosing
regimen of an innovative antibody drug conjugate.

On October 27, Dr.
Julie Desrivot Quénelle, PKPD Project Lead at Pierre Fabre, will give a
presentation on her team’s work in a free webinar titled “Model-based strategy
to guide the choice of clinical doses for ADC,” hosted by Olivier Barberan,
Director of Translational Medicine Solutions at Elsevier. It’s a great
opportunity to learn more about this important area of cancer research.

To join the webinar, register here.

How to Treat Polycystic Ovary Syndrome (PCOS) with Diet

Given the role that oxidant free radicals are thought to play in aging and disease, one reason fruits and vegetables may be so good for us is that they contain antioxidant compounds. As you can see at 0:20 in my video Benefits of Marjoram for Polycystic Ovary Syndrome (PCOS), different vegetables and herbs have different antioxidant content. When making a salad, for example, spinach, arugula, or red leaf lettuce may provide twice the antioxidants as butterhead lettuce, and choosing purple cabbage over green, or red onions over white can also boost the salad’s antioxidant power.

Fresh herbs are so powerful that even a small amount may double or even quadruple the antioxidant power of the entire meal. For instance, as you can see at 0:50 in my video, the total antioxidants in a simple salad of lettuce and tomato jump up by adding just a tablespoon of lemon balm leaves or half a tablespoon of oregano or mint. Adding marjoram, thyme, or sage not only adds great flavor to the salad, but effectively quadruples the antioxidant content at the same time, and adding a little fresh garlic or ginger to the dressing ups the antioxidant power even more.

Herbs are so antioxidant-rich that researchers decided to see if they might be able to reduce the DNA-damaging effects of radiation. Radioactive iodine is sometimes given to people with overactive thyroid glands or thyroid cancer to destroy part of the gland or take care of any remaining tumor cells after surgery. For days after the isotope injection, patients become so radioactive they are advised not to kiss or sleep close to anyone, including their pets, and if they breathe on a phone, they’re advised to wipe it “carefully” or cover it “with an easily removed plastic bag.” Other recommendations include “avoid[ing] splatter of radioactive urine,” not going near your kids, and basically just staying away from others as much as possible.

The treatment can be very effective, but all that radiation exposure appears to increase the risk of developing new cancers later on. In order to prevent the DNA damage associated with this treatment, researchers tested the ability of oregano to protect chromosomes of human blood cells in vitro from exposure to radioactive iodine. As you can see at 2:25 in my video, at baseline, about 1 in 100 of our blood cells show evidence of chromosomal damage. If radioactive iodine is added, though, it’s more like 1 in 8. What happens if, in addition to the radiation, increasing amounts of oregano extract are added? Chromosome damage is reduced by as much 70 percent. Researchers concluded that oregano extract “significantly protects” against DNA damage induced by the radioactive iodine in white blood cells. This was all done outside the body, though, which the researchers justified by saying it wouldn’t be particularly ethical to irradiate people for experimental research. True, but millions of people have been irradiated for treatment, and researchers could have studied them or, at the very least, they could have just had people eat the oregano and then irradiate their blood in vitro to model the amount of oregano compounds that actually make it into the bloodstream.

Other in vitro studies on oregano are similarly unsatisfying. In a comparison of the effects of various spice extracts, including bay leaves, fennel, lavender, oregano, paprika, parsley, rosemary, and thyme, oregano beat out all but bay leaves in its ability to suppress cervical cancer cell growth in vitro while leaving normal cells alone. But people tend to use oregano orally—that is, they typically eat it—so the relevance of these results are not clear.

Similarly, marjoram, an herb closely related to oregano, can suppress the growth of individual breast cancer cells in a petri dish, as you can see at 3:53 in my video, and even effectively whole human breast tumors grown in chicken eggs, which is something I’ve never seen before. Are there any clinical trials on oregano-family herbs on actual people? The only such clinical, randomized, control study I could find was a study on how marjoram tea affects the hormonal profile of women with polycystic ovary syndrome (PCOS). The most common cause of female fertility problems, PCOS affects up to one in eight young women and is characterized by excessive male hormones, resulting in excess body or facial hair, menstrual irregularities, and cysts in one’s ovaries that show up on ultrasounds.

Evidently, traditional medicine practitioners reported marjoram tea was beneficial for PCOS, but it had never been put to the test…until now. Drinking two daily cups of marjoram tea versus a placebo tea for one month did seem to beneficially affect the subjects’ hormonal profiles, which seems to offer credence to the claims of the traditional medicine practitioners. However, the study didn’t last long enough to confirm that actual symptoms improved as well, which is really what we care about.

Is there anything that’s been shown to help? Well, reducing one’s intake of dietary glycotoxins may help prevent and treat the disease. Over the past 2 decades there has been increasing evidence supporting an important contribution from food-derived advanced glycation end products (AGEs)…[to] increased oxidative stress and inflammation, processes that play a major role in the causation of chronic diseases,” potentially including polycystic ovary syndrome (PCOS). Women with PCOS tend to have nearly twice the circulating AGE levels in their bloodstream, as you can see at 0:33 in my video Best Foods for Polycystic Ovary Syndrome (PCOS). 

PCOS may be the most common hormonal abnormality among young women in the United States and is a common cause of infertility, menstrual dysfunction, and excess facial and body hair. The prevalence of obesity is also higher in women with PCOS. Since the highest AGE levels are found in broiled, grilled, fried, and roasted foods of “mostly animal origin,” is it possible that this causal chain starts with a bad diet? For instance, maybe eating lots of fried chicken leads to obesity, which in turn leads to PCOS. In that case, perhaps what we eat is only indirectly related to PCOS through weight gain. No, because the same link between high AGE levels and PCOS was found in lean women as well.

“As chronic inflammation and increased oxidative stress have been incriminated in the pathophysiology [or disease process] of PCOS, the role of AGEs as inflammatory and oxidant mediators, may be linked with the metabolic and reproductive abnormalities of the syndrome.” Further, the buildup of AGE inside polycystic ovaries themselves suggests a potential role of AGEs contributing to the actual disease process, beyond just some of its consequences.

RAGE is highly expressed in ovarian tissues. The receptor in the body for these advanced glycation end products, the “R” in RAGE, is concentrated in the ovaries, which may be particularly sensitive to its effect. So, AGEs might indeed be contributing to the cause of PCOS and infertility.

Does this mean we should just cut down on AGE-rich foods, such as meat, cheese, and eggs? Or hey, why not come up with drugs that block AGE absorption? We know AGEs have been implicated in the development of many chronic diseases. Specifically, food-derived AGEs play an important role because diet is a major source of these pro-inflammatory AGEs. Indeed, cutting down on these dietary glycotoxins reduces the inflammatory response, but the “argument is often made that stewed chicken would be less tasty than fried chicken…” Why not have your KFC and eat it, too? Just take an AGE-absorption blocking drug every time you eat it to reduce the absorption of the toxins. What’s more, it actually lowers AGE blood levels. This oral absorbent drug, AST-120, is just a preparation of activated charcoal, like what’s used for drug overdoses and when people are poisoned. I’m sure if you took some ipecac with your KFC, your levels would go down, too.

There’s another way to reduce absorption of AGEs, and that’s by reducing your intake in the first place. It’s simple, safe, and feasible. The first step is to stop smoking. The glycotoxins in cigarette smoke may contribute to increased heart disease and cancer in smokers. Then, decrease your intake of high-AGE foods, increase your intake of foods that may help pull AGEs out of your system, like mushrooms, and eat foods high in antioxidants, like berries, herbs, and spices. “Dietary AGE intake can be easily decreased by simply changing the method of cooking from a high dry heat application to a low heat and high humidity…” In other words, move away from broiling, searing, and frying to more stewing, steaming, and boiling.

What we eat, however, may be more important than how we cook it. At 4:00 in my video, I include a table showing the amounts of AGEs in various foods. For instance, boiled chicken contains less than half the glycotoxins of roasted chicken, but even deep-fried potatoes have less than boiled meat. We can also eat foods raw, which doesn’t work as well as for blood pudding, but raw nuts and nut butters may contain about 30 times less glycotoxins than roasted, and we can avoid high-AGE processed foods, like puffed, shredded, and flaked breakfast cereals.

Why does it matter? Because study after study has shown that switching to a low-AGE diet can lower the inflammation within our bodies. Even just a single meal high in AGEs can profoundly impair our arterial function within just two hours of consumption. At 4:54 in my video, you can see the difference between a meal of fried or broiled chicken breast and veggies compared with steamed or boiled chicken breast and veggies. Same ingredients, just different cooking methods. Even a steamed or boiled chicken meal can still impair arterial function, but significantly less than fried or broiled.

“Interestingly, the amount of AGEs administered [to subjects] during the HAGE [high-AGE] intervention was similar to the average estimated daily intake by the general population,” who typically follow the standard American diet. This is why we can decrease inflammation in people by putting them on a low-AGE diet, yet an increase in inflammation is less apparent when subjects switch from their regular diet to one high in AGEs. Indeed, they were already eating a high-AGE diet with so many of these glycotoxins.

Do we have evidence that reducing AGE intake actually helps with PCOS? Yes. Within just two months, researchers found differences from subjects’ baseline diets switched to a high-AGE diet and then to a low-AGE diet, with parallel changes in insulin sensitivity, oxidative stress, and hormonal status, as seen at 5:54 in my video. The take-home learning? Those with PCOS may want to try a low-AGE diet, which, in the study, meant restricting meat to once a week and eating it only boiled, poached, stewed, or steamed, as well as cutting out fast-food-type fare and soda.

What if instead of eating steamed chicken, we ate no meat at all? Rather than measuring blood levels, which vary with each meal, we can measure the level of glycotoxins stuck in our body tissues over time with a high-tech device that measures the amount of light our skin gives off because AGEs are fluorescent. And, not surprisingly, this turns out to be a strong predictor of overall mortality. So, the lower our levels, the better. The “one factor that was consistently associated with reduced [skin fluorescence]: a vegetarian diet.” This “suggests that a vegetarian diet may reduce exposure to preformed dietary AGE…potentially reduc[ing] tissue AGE,” as well as chronic disease risk


What’s so great about antioxidants? See my videos:

Just how many antioxidants do we need? Check out:

For a few simple tips on how to quickly boost the antioxidant content of your food with herbs and spices, see my video Antioxidants in a Pinch.

I touched on the benefits of spearmint tea for PCOS in Enhancing Athletic Performance with Peppermint. Another sorely under-recognized gynecological issue is endometriosis, which I discuss in How to Treat Endometriosis with Seaweed.

Because of AGEs, I no longer toast nuts or buy roasted nut butters, which is disappointing because I really enjoy those flavors so much more than untoasted and unroasted nuts. But, as Dr. McDougall likes to say, nothing tastes as good as healthy feels. For more on why it’s important to minimize our exposure to these toxic compounds, see:

In health,
Michael Greger, M.D.

PS: If you haven’t yet, you can subscribe to my free videos here and watch my live presentations:

 

 

Cleveland Clinic Names Top 10 Medical Innovations For 2021

Cleveland Clinic Names Top 10 Medical Innovations For 2021

Cleveland Clinic’s top clinicians and researchers present the top 10 medical innovations transforming medical advancements and new awards to recognize healthcare innovation.


The list of breakthrough technologies was selected by a committee of Cleveland Clinic subject matter experts, led by Will Morris, M.D., executive medical director for Cleveland Clinic Innovations, and Akhil Saklecha, M.D., managing director of Cleveland Clinic Ventures.

Here is a look at the top 10 medical innovations for 2021 with the power to transform healthcare in the next year:

1. Gene Therapy for Hemoglobinopathies

2. Novel Drug for Primary-Progressive Multiple Sclerosis

3. Smartphone-Connected Pacemaker Devices

4. New Medication for Cystic Fibrosis   

5. Universal Hepatitis C Treatment   

6. Bubble CPAP for Increased Lung Function in Premature Babies   

7. Increased Access to Telemedicine through Novel Practice and Policy Changes  

8. Vacuum-Induced Uterine Tamponade Device for Postpartum Hemorrhage   

9. PARP Inhibitors for Prostate Cancer   

10. Immunologics for Migraine Prophylaxis   

AWS, PHDA Collaborate to Develop Breast Cancer Screening and Depression Machine Learning Models

AWS, PHDA Collaborate to Develop Breast Cancer Screening and Depression Machine Learning Models

What You Should Know:

– Amazon Web Services (AWS) and the Pittsburgh Health Data Alliance (PHDA) announce a collaboration to produce more accurate machine learning models for breast cancer screening and depression.

– In work funded through the PHDA-AWS collaboration, a research team led by Shandong Wu, an associate professor at the University of Pittsburgh Department of Radiology, is using deep-learning systems to analyze mammograms in order to predict the short‐term risk of developing breast cancer. 

– A team of experts in computer vision, deep learning,
bioinformatics, and breast cancer imaging, including researchers from the
University of Pittsburgh Medical Center (UPMC), the University of Pittsburgh,
and Carnegie Mellon University (CMU), are working together to develop a more
personalized approach for patients undergoing breast cancer screening.


Last August, the Pittsburgh Health Data Alliance (PHDA)
and Amazon Web Services (AWS)
announced a new collaboration to advance innovation in areas such as cancer
diagnostics, precision medicine, electronic health records,
and medical imaging. One year later: AWS collaboration with Pittsburgh Health
Data Alliance begins to pay dividends with new machine learning innovation.

Researchers from the University of Pittsburgh Medical Center
(UPMC), the University of Pittsburgh, and Carnegie Mellon University (CMU),
who were already supported by the PHDA,  received additional support
from  Amazon Research Awards to use machine learning
techniques to study breast cancer risk, identify depression markers, and
understand what drives tumor growth, among other projects.


Accurate Machine Learning Models for Breast Cancer Screening
and Depression

In work funded through the PHDA-AWS collaboration, a
research team led by Shandong Wu, an associate professor in the University of
Pittsburgh Department of Radiology, is using deep-learning systems to analyze
mammograms in order to predict the short‐term risk of developing breast
cancer.  A team of experts in computer vision, deep learning,
bioinformatics, and breast cancer imaging are working together to develop a
more personalized approach for patients undergoing breast cancer screening.

Wu and his colleagues collected 452 de-identified normal
screening mammogram images from 226 patients, half of whom later developed
breast cancer and half of whom did not. Leveraging AWS tools, such as
Amazon SageMaker,
they used two different machine learning models to analyze the images for
characteristics that could help predict breast cancer risk. As they reported in
the American Association of Physicists in Medicine, both
models consistently outperformed the simple measure of breast density, which
today is the primary imaging marker for breast cancer risk,  The team’s
models demonstrated between 33% and 35% improvement over these existing
models, based on metrics that incorporate sensitivity and specificity.


Why It Matters

“This preliminary work demonstrates the feasibility and promise of applying deep-learning methodologies for in-depth interpretation of mammogram images to enhance breast cancer risk assessment,” said Dr. Wu. “Identifying additional risk factors for breast cancer, including those that can lead to a more personalized approach to screening, may help patients and providers take more appropriate preventive measures to reduce the likelihood of developing the disease or catching it early on when interventions are most effective. “